Predicate Devices

K072344, K103664, K072564, K150140, K111303, K090195

Reference Devices

K072344, K103664, K072564, K150140, K111303, K090195

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a multi-laser and pulsed light system with various handpieces for different dermatological and surgical procedures. There is no mention of AI, ML, or any form of intelligent processing of data or images within the device description or intended use. The performance studies mentioned are pre-series tests, not studies related to AI/ML model performance.

Therapeutic

Yes.
The device is intended for the treatment of various medical conditions, including benign vascular and pigmented lesions, acne scars, wrinkles, and other skin conditions.

Diagnostic

No

The device is described as a "multilaser and pulsed light system, designated to act on some common conditions of face and body." Its intended uses primarily involve treatment and physical alteration of tissues (e.g., removal of lesions, hair reduction, skin resurfacing, coagulation, cutting), not the diagnosis or detection of diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "multilaser and pulsed light system" composed of a "modular platform" and "interchangeable handpieces." This indicates a hardware-based medical device that uses lasers and pulsed light for treatment, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The description and intended uses clearly state that this device is a laser and pulsed light system designed to directly treat various skin conditions and perform surgical procedures on the human body. It acts on the body, not on samples taken from the body.

The device is a therapeutic device used for various dermatological and surgical applications.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:

-treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins;

-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;

-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);

verrucae, skin tags, seborrheic keratosis;

reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
coagulation and hemostasis of soft tissue;

-the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:

Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions

Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:

Benign vascular lesions such as, but not limited to treatment of:

Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas

-Benign cutaneous lesions, such as, but not limited to:

Warts; Scars; Striae; Psoriasis

-Benign pigmented lesions such as, but not limited to:

Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques

Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to:

Periocular wrinkles; Perioral wrinkles;

-Laser skin resurfacing procedures for the treatment of:

Acne scars; Wrinkles

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

-Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:

-Incision, excision, ablation, vaporization of soft tissue.

Tattoo removal: Light blue; Yellow; Red; Green
Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi

-Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi

-Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques

The 2940 nm Er:YAG Laser Module handpiece is indicated for:

Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:

A. Acne scars
. Wrinkles

The 2940 nm Er: Yag Fractional tips are indicated for:

Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

IPL 400-1200 run handpiece is indicated for:

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia,

hyperpigmentation, melasma, and ephelides (freckles).

· The treatment of benign cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

·Use on all skin types (Fitzpatrick I-VI).

IPL500-1200 nm handpiece is indicated for:

· The treatment of moderate inflammatory acne (acne vulgaris).

· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,

dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

•Use on Fitzpatrick skin types I-V.

IPL 550-1200 nm handpiece is indicated for:

· The treatment of moderate inflammatory acne Vulgans.

· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

IPL 580-1200 run handpiece is indicated for:

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

IPL 620-1200 nm handpiece is iodicated for:

· The treatment of tattoos.

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait.

· The treatment of cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

: The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6. 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin.

IPL 755-1200 nm handpiece is indicated for:

• The treatment of tattoos.

· The treatment of moderate ioflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles).

· The treatment of cutaneous lesions iocluding warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.

· The treatment of pseudofolliculitis barbae (PFB).

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

·Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Product codes

GEX, ONG, ONF

Device Description

The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following handpieces are available:

1. Handpiece Nd:Yag Laser contains a flash lamp excited source that emits at 1064nm, with 2 different modalities: long pulse (ms) and short pulse (us). The handpiece can be equipped with different spots and also with an optical fiber. A pointing laser helps to guide the operator during the treatment. With this laser it is possible to treat vascular lesions, pigmented lesions, tattoos, scars, soft tissue, hair removal treatments (long pulse) and pigmented and vascular lesions, wrinkles and podiatry (short pulse). This laser is class IV according to the Standard EN60825-1.
1. Handpiece Nd: Yag Laser contains a flash lamp excited source that emits 1064 and 532 nm Qs (0-Switched). The pulse duration is very short (ns), typical characteristic of OS lasers. The handbiece can be equipped with different spots. A pointing laser helps to guide the operator during the treatment. The Qs laser is ideal for the treatment of vascular lesions, scars, pigmented lesions, skin resurfacing (1064 nm) and soft tissue, tattoo, vascular lesions, pigmented lesions (532 nm). This laser is class IV according to the Standard EN60825-1.
1. Handpiece Erbium Laser contains a flash lamp excited source that emits at 2940 nm. The handpiece can be equipped with different spots; two of them are fractional, so they divide the shot in several microbeams. The Er:Yag laser is ideal for soft tissue, skin resurfacing, skin lesions treatments. This laser is class IV according to the Standard EN60825-1.
1. Handpiece Erbium Glass Laser contains a flash lamp excited source that emits at 1540 mm. The handpiece can be equipped with two spots, both fractional, that divide the shot in several microbeams. The Er:Glass is ideal for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue, for example scar treatments. This laser is class IV according to the Standard EN60825-1.
1. Handpiece Pulsed Light contains a xenon lamp that emits from 400 and 1200 nm. On this handpiece it is possible to change easily the guide light, equipped with a specific light filter and to use thus that one most adequate for the individual photo type. It is possible also to have a cooling for the guides, as optional. With the use of this handpiece is possible to perform pigmented lesions, scars, vascular lesions, tattoos, hair removal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Pre-series tests have been performed to support the evidence that performance of SUPERBIUM are aligned with the identified intended uses. Animal and clinical studies were not necessary to demonstrate that the performances are comparable to the predicate devices.

Key Metrics

Not Found

Predicate Device(s)

K072344, K103664, K072564, K150140, K111303, K090195

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 12, 2016

Bios S.r.l Mr. Riccardo Pisati Regulatory Affairs Via Guido Rossa, 10/12 Vimodrone, IT-20090 Milan

Re: K153229 Trade/Device Name: Superbium Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ONG, ONF Dated: March 21, 2016 Received: March 25, 2016

Dear Mr. Pisati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K153229

Device Name Superbium

Indications for Use (Describe)

The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:

-treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins;

-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;

-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);

verrucae, skin tags, seborrheic keratosis;

reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
coagulation and hemostasis of soft tissue;

-the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:

Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions

Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:

Benign vascular lesions such as, but not limited to treatment of:

Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas

-Benign cutaneous lesions, such as, but not limited to:

Warts; Scars; Striae; Psoriasis

-Benign pigmented lesions such as, but not limited to:

Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques

Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to:

Periocular wrinkles; Perioral wrinkles;

-Laser skin resurfacing procedures for the treatment of:

Acne scars; Wrinkles

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

-Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:

-Incision, excision, ablation, vaporization of soft tissue.

Tattoo removal: Light blue; Yellow; Red; Green
Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi

-Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi

3

-Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques

The 2940 nm Er:YAG Laser Module handpiece is indicated for:

Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:

Laser skin resurfacing procedures for the tr

A. Acne scars

Acne scars . . Wrinkles
The 2940 nm Er: Yag Fractional tips are indicated for:

Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

IPL 400-1200 run handpiece is indicated for:

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia,

hyperpigmentation, melasma, and ephelides (freckles).

· The treatment of benign cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

·Use on all skin types (Fitzpatrick I-VI).

IPL500-1200 nm handpiece is indicated for:

· The treatment of moderate inflammatory acne (acne vulgaris).

· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,

dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime.

•Use on Fitzpatrick skin types I-V.

IPL 550-1200 nm handpiece is indicated for:

· The treatment of moderate inflammatory acne Vulgans.

· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.
· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

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IPL 580-1200 run handpiece is indicated for:

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

IPL 620-1200 nm handpiece is indicated for:

· The treatment of tattoos.

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait.

· The treatment of cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

: The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.

IPL 755-1200 nm handpiece is indicated for:

• The treatment of tattoos.

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).

· The treatment of cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.

· The treatment of pseudofolliculitis barbae (PFB).

· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

·Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

D Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Bios s.r.l. rev.03 pag. 1 of 26

Section 5 510(k) Summary

SUBMITTER I.

Applicant Information	Bios s.r.l.
	Via Guido Rossa, 10/12
	20090 Vimodrone (MI) – Italy
Contact	Ing. Aldo Casalino
Date Prepared	3 November 2015
II. DEVICE

Device Trade Name	SUPERBIUM
Common Name	Medical Laser System
Regulatory class	II
Classification Name	Laser surgical instrument for use in general and plastic surgery and in
dermatology (21 CFR 878.4810)

Product Code

GEX, ONG, ONF

III. PREDICATE DEVICE

510(k) Number	Pro Code	Trade Name	Applicant
K072344	GEX 21 CFR 878.4810
FTC 21 CFR 878.4630	APL MEDICAL SYSTEM	BIOS
K103664	GEX, ONG
21 CFR § 878.4810	ICON AESTHETIC SYSTEM	Palomar
K072564	GEX, FTC, HHR, LNK
21 CFR 878.4810	HARMONY XL
MULTI APPLICATION PLATFORM	ALMA
K150140	GEX 21 CFR 878.4810	DERMABLATE	ASCLEPION
K111303	GEX 21 CFR 878.4810	OMNIMAX	SHARPLIGHT
TECHNOLOGIES
K090195	GEX 21 CFR 878.4810	LUX 1540	PALOMAR

IV. DEVICE DESCRIPTION

The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable

7

510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 2 of 26

handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following handpieces are available:

1. Handpiece Nd:Yag Laser contains a flash lamp excited source that emits at 1064nm, with 2 different modalities: long pulse (ms) and short pulse (us). The handpiece can be equipped with different spots and also with an optical fiber. A pointing laser helps to guide the operator during the treatment. With this laser it is possible to treat vascular lesions, pigmented lesions, tattoos, scars, soft tissue, hair removal treatments (long pulse) and pigmented and vascular lesions, wrinkles and podiatry (short pulse). This laser is class IV according to the Standard EN60825-1.
1. Handpiece Nd: Yag Laser contains a flash lamp excited source that emits 1064 and 532 nm Qs (0-Switched). The pulse duration is very short (ns), typical characteristic of OS lasers. The handbiece can be equipped with different spots. A pointing laser helps to guide the operator during the treatment. The Qs laser is ideal for the treatment of vascular lesions, scars, pigmented lesions, skin resurfacing (1064 nm) and soft tissue, tattoo, vascular lesions, pigmented lesions (532 nm). This laser is class IV according to the Standard EN60825-1.
1. Handpiece Erbium Laser contains a flash lamp excited source that emits at 2940 nm. The handpiece can be equipped with different spots; two of them are fractional, so they divide the shot in several microbeams. The Er:Yag laser is ideal for soft tissue, skin resurfacing, skin lesions treatments. This laser is class IV according to the Standard EN60825-1.
1. Handpiece Erbium Glass Laser contains a flash lamp excited source that emits at 1540 mm. The handpiece can be equipped with two spots, both fractional, that divide the shot in several microbeams. The Er:Glass is ideal for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue, for example scar treatments. This laser is class IV according to the Standard EN60825-1.
1. Handpiece Pulsed Light contains a xenon lamp that emits from 400 and 1200 nm. On this handpiece it is possible to change easily the guide light, equipped with a specific light filter and to use thus that one most adequate for the individual photo type. It is possible also to have a cooling for the guides, as optional. With the use of this handpiece is possible to perform pigmented lesions, scars, vascular lesions, tattoos, hair removal.

8

510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 3 of 26

V. Indication for Use

The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:

treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins;
treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
tattoos (significant reduction in the intensity of black and/or blue-black tattoos);

verrucae, skin tags, seborrheic keratosis;

reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar:
coagulation and hemostasis of soft tissue;
the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:

Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:

Benign vascular lesions such as, but not limited to treatment of:

Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas

Benign cutaneous lesions, such as, but not limited to:

Warts; Scars; Striae; Psoriasis

Benign pigmented lesions such as, but not limited to:

Lentigos (age spots); Solar lentigos (sun spots); Cafè-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques

Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to:

Periocular wrinkles; Perioral wrinkles;

Laser skin resurfacing procedures for the treatment of:

Acne scars; Wrinkles

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:

Incision, excision, ablation, vaporization of soft tissue.
Tattoo removal: Light blue; Yellow; Red; Green
Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi

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510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 4 of 26

Benign pigmented lesions: Cafè-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi
Other pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques

The 2940 nm Er: Y AG Laser Module handpiece is indicated for:

Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:

Acne scars ●
. Wrinkles

The 2940 nm Er: Yag Fractional tips are indicated for:

Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to:

glands) such as, but not limited to:
Dermatology and plastia Surgery Skin ros

Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia: Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

IPL 400-1200 run handpiece is indicated for:

· The treatment of moderate inflanunatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions including dyschromia,

hyperpigmentation, inelasma, and ephelides (freckles).

· The treatment of cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas,

poikiloderma of Civatte, leg veins and venous malformations.

·Use on all skin types (Fitzpatrick I-VI).

IPL500-1200 nm handpiece is indicated for:

· The treatment of moderate inflanunatory acne (acne vulgaris).

· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe..au-lait macules.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte. leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defmed as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

·Use on Fitzpatrick skin types I-V.

IPL 550-1200 nm handpiece is indicated for:

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510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 5 of 26

· The treatment of moderate mtlammatory acne VUlgans.

· The treatment of benign pigmented epidermal lesions, includiog dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, includiog scars and striae.

· The treatment of benign cutaneous vascular lesions, includiog port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veios and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

IPL 580-1200 run handpiece is indicated for:

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI).

IPL 620-1200 nm handpiece is iodicated for:

· The treatment of tattoos.

· The treatment of moderate inflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpiementation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait.

· The treatment of cutaneous lesions including warts, scars and striae.

· The treatment of benign cutaneous vascular lesions includiog port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

: The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin.

IPL 755-1200 nm handpiece is indicated for:

· The treatment of tattoos.

· The treatment of moderate ioflammatory acne vulgaris.

· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles).

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510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 6 of 26

· The treatment of cutaneous lesions iocluding warts, scars and striae.

· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.

· The treatment of pseudofolliculitis barbae (PFB).

· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.

12

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

By comparing SUPERBIUM to the legally marketed predicate devices, it is substantially equivalent in terms of intended use and utilizes similar functional features including energy source, frequency, fluency, pulse width.

The general features of SUPERBIUM are similar to those of the predicates in particular as regards the classification IV laser, the equipment of a the cooling system and the electrical specifications. Also the predicate devices are equipped with a touch screen and with a control SW.

The intended use of each handpiece of SUPERBIUM are identical to those of the handpieces of the predicates and also the technical characteristics are the same, in particular:

handpiece Nd:Yag Long Pulse of SUPERBIUM with the wavelength of 1064 nm applies an output power and a maximum energy per pulse operating in the same range of Harmony XL K072564 and the Icon Aesthetic System K103664.
The emission frequency of the handpiece Nd:Yag Long Pulse of SUPERBIUM is the same of Harmony XL K072564 and it is in the same interval the Icon Aesthetic System K103664.
handpiece Nd:Yag Short Pulse of SUPERBIUM with the wavelength of 1064 nm applies an output power and a maximum energy per pulse operating, in the same range of APL Medical System K072344.
handpiece Nd:YAG Q-Switched of SUPERBIUM with a wavelength of 1064+532 nm applies a maximum output power and a maximum energy per pulse similar to those of the Harmony XL K072564. The pulse duration is in the same range of predicates and fluence value is similar to that of the Harmony XL K072564. The emission frequency of the handpiece Nd: YAG Q-Switched of SUPERBIUM is the same of predicates.
handpiece Er.Yag of SUPERBIUM with a wavelength of 2940 nm applies a maximum output power in the same range of values APL Medical System K072344 and of the Dermablate K150140 and a maximum energy per pulse that is the same value of Dermablate K150140. The value of the fluence the same to predicate devices Dermablate K150140 for the same spot size. The emission frequency of the handpiece Er: Yag of SUPERBIUM is similar to that of the Dermablate K150140.

13

handpiece Er:Yag Fractional Tip of SUPERBIUM is equal to the predicate SHARPLIGHT - TECHNOLOGIES OMNIMAX K1113603. The numbers of dots are the same, and also the fluencies are very similar. The frequency emission is the same.
handpiece Er:Yag Glass of SUPERBIUM with a wavelength of 1540 nm is equal to the predicate -Palomar LUX 540 K090195. In particular they have same parameters for max energy, dot density and consequently the fluence parameters are the same. Also the pulse duration and the emission frequency are equal to the predicate.
the IPL handpiece of SUPERBIUM has the same emission spectrum (400 1200 nm) of the Harmony XL K072564 and of APL Medical System K072344. The standard filters equipment is the same and also the maximum energy per pulse is in the same range of mentioned predicates. The maximum fluence valueis the same and the values of the maximum pulse duration and frequency are similar.

14

Base: 50x54x38

Dimensions (LxPxH) cm

50x45x25 cm

Section V

A) General Features
Device
Basic
Technical
Data	Applicant	BIOS	BIOS	Palomar	ALMA	ASCLEPION	SHARPLIGHT
TECHNOLOGIES	PALOMAR
	Device Name	SUPERBIUM	APL MEDICAL
SYSTEM	ICON AESTHETIC
SYSTEM	HARMONY XL	DERMABLATE	OMNIMAX	LUX 1540
Handpiece
	510k	---	K072344	K103664	K072564	K150140	K111303	K090195
	Classification	GEX 21 CFR
878.4810,
ONF 21CFR 878.4810	GEX 21 CFR 878.4810
FTC 21 CFR 878.4630	GEX, ONG
21 CFR § 878.4810	GEX, FTC, HHR, LNK
21 CFR 878.4810	GEX
878.4810	GEX
878.4810	GEX
878.4810
Intended Use		Nd:Yag Handpiece
LP	See Table B	See Table B	See Table B	-	-	-
		Nd:Yag Handpiece
SP	See Table C	-	-	-	-	-
		Nd:Yag Q-Switched
Handpiece	See Table D	-	See Table D	-	-	-
		Er:Yag Handpiece	See Table E	-	-	See Table E	-	-
		Er:Yag Handpiece
Fractional	-	-	-	-	See Table F	-
		Er:Yag Glass
Handpiece	-	-	-	-	-	See Table G
		IPL Handpiece	See Table H	-	See Table H	-	-	-
Display		Display LCD 10.4"
touch screen.	LCD Color Display
"touch screen".	LCD Color Display
"touch screen".	LCD Color display
"touch screen"	Display "touch
screen"	Display "touch
screen"	-
Voltage		110V Ac ±10%	110V Ac ±10%	90 - 264 VAC	100 -120 VAC	110V Ac	100-240 V	-
Frequency		60 Hz ± 1%	60 Hz ± 1%	50 - 60 Hz	50 - 60 Hz	50 - 60 Hz	50-60Hz,	-
Absorbed power		12A (average)— 24A
max	8A (average)—
12,5A max	20 A	20 A	500 VA	max 1-A	-
Cooling system		YES	YES	YES	YES	YES	YES	-
Laser class		IV	IV	IV	IV	IV	IV	IV
Weight		35 Kg	Approx 21 Kg	47.17 Kg	Upper Unit 15 kg,
Lower Unit 45 kg	75 Kg	70kg	-

58x54x103 cm

39.7 x 55 x 123 cm

36 x 60 x 93 cm

56 x 42 x 105 cm

15

B)Nd:Yag Handpiece Long Pulse

Applicant	BIOS	BIOS	ALMA	PALOMAR
Device Name	SUPERBIUM	APL MEDICAL
SYSTEM	HARMONY XL	ICON AESTHETIC SYSTEM
510k	---	K072344	K072564	K103664
Classification	GEX 21 CFR 878.4810, ONF	GEX, FTC	GEX, FTC, HHR, LNK	GEX, ONG
Laser source	Nd:YAG LP	Nd:YAG LP	Nd:Yag LP	Nd:Yag
Wavelenght	1064 nm	1064 nm	1064 nm	1064 nm
Output power	45W max	20W max	40W max	50 W
Max energy per pulse	LP: 45J (max)	LP: 20J (max)	40 J	50 J
Beam diameter (spot)	1, 2, 3, 4, 5, 6, 9, 11,12,13,14,15 mm	2; 5 mm	6 mm	1,5; 3; 6; 10 mm
Fluence	500J/cm2 (max);
3 mm: 500J/cm2 (max);
6 mm: 160 J/cm2	285 J/cm2 (spot
3mm)	30-450 J/cm2 (2);
30-150 J/cm2 (6);
30-450 J/cm2 (10)	1,5 mm - 250/750 J/cm2;
3 mm - 70/450 J/cm2;
6 mm - 16/140 J/cm2;
10 mm - 7/50 J/cm2
Pulse duration	LP: 1 - 25 ms	LP: 5 - 25 ms	8-15ms (2);
40-60 ms (6);
15 ms (10)	10 - 100 ms
Emission frequency	LP: 1 Hz (max)	LP: 1 Hz (max)	1 Hz	0,2 - 2 Hz
Intended Use	The Nd:Yag 1064 Laser Handpiece
(Long Pulsed) is intended for:		1064 nm Long Pulsed Module
Handpieces
The 1064 nm Nd:YAG Laser Module
handpieces (Long Pulsed and Q-
Switched with and without contact-
cooling) are indicated for treatment
and clearance of:	The 1064 Laser Handpiece is
intended for
	treatment of vascular lesions
such as but not limited to, port
wine stains, hemangiomas,
telangiectasias, rosacea, venus
lake, facial and leg veins;	6. treatment of
capillaries,
teleangiectasies and
vascular lesions (LP)	• Benign vascular lesions such as,
but not limited to treatment of:
Port wine stains; Hemangiomas;
Warts; Superficial and deep
telangiectasias (venulectasias);
Reticular veins (0.1-4.0 mm dia.) of
the leg; Rosacea; Venus lake; Leg
veins; Spider veins; Poikiloderma of
Civatte; Angiomas	treatment of vascular lesions
such as but not limited to,
port wine stains,
hemangiomas,
telangiectasias, rosacea,
venus lake, facial and leg
veins;
Applicant	BIOS	BIOS	ALMA	PALOMAR
	SUPERBIUM	APL MEDICAL SYSTEM
Device Name			HARMONY XL	ICON AESTHETIC SYSTEM
510k	---	K072344	K072564	K103664
	treatment of benign pigmented
lesions such as, but not limited
to, senile lentigines (age spots),
solar lentigos (sun spots),
pigmented seborrheic
keratoses, nevi, chloasma, cafe-
au-lait macules, and plaques;		• Benign cutaneous lesions, such as,
but not limited to:
Warts; Scars; Striae; Psoriasis	treatment of benign
pigmented lesions such as,
but not limited to, senile
lentigines (age spots), solar
lentigos (sun spots),
pigmented seborrheic
keratoses, nevi, chloasma,
cafe-au-lait macules, and
plaques;
	tattoos (significant reduction in
the intensity of black and/or
blue-black tattoos);
verrucae, skin tags, seborrheic
keratosis;		• Benign pigmented lesions such as,
but not limited to:
Lentigos (age spots); Solar lentigos
(sun spots); Cafè-au-lait macules;
Seborrheic keratoses; Nevi and
nevus of Ota; Chloasma; Verrucae;
Skin tags; Keratoses; The removal of
black, blue or green tattoos
(significant reduction in the
intensity of black and /or blue/black
tattoos); Plaques	tattoos (significant reduction
in the intensity of black
and/or blue-black tattoos);
verrucae, skin tags,
seborrheic keratosis;
	reduction of red pigmentation
in hypertrophic and keloid scars
where vascularity is an integral
part of the scar;		Laser skin resurfacing procedures
for the treatment of:
Acne scars; Wrinkles	reduction of red
pigmentation in hypertrophic
and keloid scars where
vascularity is an integral part
of the scar;
	coagulation and hemostasis of
soft tissue;		Reduction of red pigmentation in
hypertrophic and keloid scars where
vascularity is an integral part of the
scar.	coagulation and hemostasis
of soft tissue;
Section V			pag. 12 of 26
Applicant	BIOS	BIOS	ALMA	PALOMAR
Device Name	SUPERBIUM	APL MEDICAL
SYSTEM	HARMONY XL	ICON AESTHETIC SYSTEM
510k	---	K072344	K072564	K103664
	the removal of unwanted hair
for skin types I-VI, and to effect
stable long-term permanent
hair reduction;	1. The removal of
unwanted hair and
to effect stable long-
term or permanent
hair reduction (LP)	1064 nm Long Pulsed Only Nd:YAG
Laser Module Handpieces
The 1064 nm Nd:YAG lasers (Long
Pulsed only, with and without
contact-cooling) is indicated for:

Removal of unwanted hair, for
stable long-term, or permanent,
hair reduction through selective
targeting of melanin in hair follicles.
Removal or lightening of unwanted
hair (with and without adjuvant
preparation)
Treatment of pseudofolliculitis
barbae (PFB)
Indicated for use on all skin types
(Fitzpatrick I-VI), including tanned | the removal of unwanted hair
for skin types I-VI, and to
effect stable long-term
permanent hair reduction |

16

Section V

Bios s.r.l. rev.03

17

Section V

Bios s.r.l.

rev.03

18

Bios s.r.l. rev.03 pag. 13 of 26

C)Nd:Yag Handpiece - Short Pulse

Applicant	BIOS	BIOS	Applicant	BIOS	BIOS	ALMA
Device Name	SUPERBIUM	APL MEDICAL SYSTEM	Device Name	SUPERBIUM	APL MEDICAL
SYSTEM	HARMONY XL
510k	---	K072344	510k	---	K072344	K072564
Classification	GEX 21 CFR 878.4810, ONF	GEX, FTC	Classification	GEX 21 CFR 878.4810,
ONF 21 CFR 878.4810	GEX, FTC	GEX, FTC, HHR, LNK
Laser source	Nd:YAG SP	Nd:YAG SP	Laser source	Nd:YAG Q - Switched	Nd:YAG — Q
Switched	Nd:YAG - Q Switched
Wavelenght	1064 nm	1064 nm	Wavelenght	1064+532 nm.	1064+532 nm.	1064+532 nm.
Output power	45W max	20W max	Output power	10W max	1,2 W max	0,4 - 6 W
Max energy per pulse	1000 mJ	2000 J (max)	Max energy per
pulse	1800 mJ (max).	1000 mJ	400- 1200 mJ
Beam diameter (spot)	6, 9	2/5 mm	Pulse duration	up to 12 ns	10 ns	20 ns
Fluence	6 mm: 3.6 J/cm2
9 mm: 1.6 J/cm2	spot 5 mm: 10 J/cm2	Fluence	180 J/cm2	32 J/cm2 (spot 2
mm)	152 J/cm2 max
Pulse duration	SP: 200 - 700 µs	SP: 100 – 500 µs	Emission
frequency (max)	5 Hz	5 Hz	1; 2; 5 Hz
Emission frequency	SP: 10Hz (max)	SP: 3 Hz (max)	Beam diameter
(spot)	2, 4, 10 mm; 1-2-3-3,5 mm	1; 3 mm	1; 2; 3;4; 5; 6 mm
Intended Use	Removal of tattoos and blemishes of the skin, the treatment of various
pigmentation lesions (SP)
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles (SP)	5. removal of tattoos and blemishes
of the skin, the treatment of various
pigmentation lesions (SP)

Laser skin treatment procedures
for the treatment of: Acne scars,
Wrinkles (SP) | Intended Use | The Nd:YAG Q-Switched Handpieces (1064 nm) are
indicated for treatment of:

Benign vascular lesions such as, but not limited to
treatment of:
Port wine stains; Hemangiomas; Warts; Superficial and deep
telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm
dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins;
Poikiloderma of Civatte; Angiomas
Benign cutaneous lesions, such as, but not limited to:
Warts; Scars; Striae; Psoriasis
Benign pigmented lesions such as, but not limited to:
Lentigos (age spots); Solar lentigos (sun spots); Cafè-au-lait
macules; Seborrheic keratoses; Nevi and nevus of Ota; | | 1064 nm Long Pulsed and Q-Switched Nd:YAG Laser
Module Handpieces
The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsec
and Q-Switched with and without contact-cooling) are
indicated for treatment and clearance of.
• Benign vascular lesions such as, but not limited to
treatment of:
Port wine stains; Hemangiomas; Warts; Superficial and deep
telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm
dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins;
Poikiloderma of Civatte; Angiomas
• Benign cutaneous lesions, such as, but not limited to:
Warts; Scars; Striae; Psoriasis
• Benign pigmented lesions such as, but not limited to: |

19

Bios s.r.l. rev.03 pag. 14 of 26

D)Nd:Yag Q-Switched Handpiece

20

Section V

Applicant	BIOS	ALMA
Device Name	SUPERBIUM	HARMONY XL
510k	---	K072564
	black, blue or green tattoos (significant reduction in the
intensity of black and /or blue/black tattoos); Plaques

Pigmented lesions to reduce lesion size, for patients with
lesions that would potentially benefit from aggressive
treatment, and for patients with lesions that have not
responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but
not limited to:
Periocular wrinkles; Perioral wrinkles;
Laser skin resurfacing procedures for the treatment of:
Acne scars; Wrinkles
Reduction of red pigmentation in hypertrophic and keloid
scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI),
including tanned skin. | | Lentigos (age spots); Solar lentigos (sun spots); Cafè-au-lait
macules; Seborrheic keratoses; Nevi and nevus of Ota;
Chloasma; Verrucae; Skin tags; Keratoses; The removal of
black, blue or green tattoos (significant reduction in the
intensity of black and /or blue/black tattoos); Plaques
• Pigmented lesions to reduce lesion size, for patients with
lesions that would potentially benefit from aggressive
treatment, and for patients with lesions that have not
responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as,
but not limited to:
Periocular wrinkles; Perioral wrinkles;
• Laser skin resurfacing procedures for the treatment of:
Acne scars; Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid
scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI),
including tanned skin. |
| | The Nd:YAG Q-Switched Handpieces (532 nm) are indicated
for treatment of:
Incision, excision, ablation, vaporization of soft tissue.
Tattoo removal: Light blue; Yellow; Red; Green
Vascular lesions: Hemangiomas (Port wine
stains/birthmarks, cavernous, cherry, spider, hemangiomas);
Angiomas (cherry, spider); Telangiectasia; Spider nevi
Benign pigmented lesions:
Cafè-au-lait (macules); Lentigines (senile and solar); Freckles
(ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota
;Becker's Nevi
Other pigmented cutaneous lesions:
Verrucae; Skin tags; Keratoses; Plaques | 5. removal of
tattoos and
blemishes of the
skin, the
treatment of
various
pigmentation
lesions
K072344 | 532 nm Long Pulsed and Q-Switched FD Nd:YAG Laser
Module Handpiece Tips
The 532 nm Frequency-Doubled (FD) Nd:YAG Laser Module
handpieces tips (Long Pulsed and Q-Switched, with and
without contact-cooling) are indicated for:
• Incision, excision, ablation, vaporization of soft tissue.
• Tattoo removal: Light blue; Yellow; Red; Green
• Vascular lesions: Hemangiomas (Port wine
stains/birthmarks, cavernous, cherry, spider, hemangiomas);
Angiomas (cherry, spider); Telangiectasia; Spider nevi
• Benign pigmented lesions:
Cafè-au-lait (macules); Lentigines (senile and solar); Freckles
(ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota
;Becker's Nevi
• Other pigmented cutaneous lesions:
Verrucae; Skin tags; Keratoses; Plaques |

E)Er:Yag Handpiece

21

Section V

Bios s.r.l.
rev.03

Applicant	BIOS	BIOS	Asclepion
Device Name	SUPERBIUM	APL MEDICAL SYSTEM	DERMABLATE
510k	---	K072344	K150140
Classification	GEX 21 CFR 878.4810,
ONF 21 CFR 878.4810	GEX, FTC	GEX
Laser source	Er:YAG	Er:YAG	Er:YAG
Wavelenght	2.940 nm.	2.940 nm.	2.940 nm.
Output power	12 W max	4 W	20 W
Max energy per
pulse	2,5 J (max).	800 mJ (max)	2,5 mJ
Beam diameter
(spot)	1/ 9 mm	2 -8 mm	1/12 mm
Fluence	316 J/cm² (spot 1 mm)	22 J/cm² (spot 2 mm)	318 J/cm² (spot 1 mm)
Emission
frequency	5 Hz	5 Hz	20 Hz
Intended Use	Coagulation, vaporization, ablation or cutting
of soft tissue (skin) in Dermatology, Plastic
Surgery, Oral Surgery, ENT, Gynecology,
General Surgery, Podiatry and Ophthalmology
(skin around the eyes).
Laser skin resurfacing procedures for the
treatment of:
Acne scars
Wrinkles	Laser skin resurfacing procedures for the
treatment of:
Acne scars
Wrinkles
Incision, excision, ablation, vaporization of soft
tissue.	Coagulation, vaporization, ablation or
cutting of soft tissue (skin) in
Dermatology, Plastic Surgery, Oral
Surgery, ENT, Gynecology, General
Surgery, Podiatry and Ophthalmology
(skin around the eyes).

22

F) Er:Yag Handpiece Fractional Tip

Applicant	BIOS	SHARPLIGHT TECHNOLOGIES
Device Name	SUPERBIUM	OMNIMAX
510k	K153229	K111303
Classification	GEX 21 CFR 878.4810,
ONF 21 CFR 878.4810	GEX
NUV, ONG, ONE, ONF
Laser source	Er:YAG	Er:YAG
Wavelenght	2.940 nm	2.940 nm
Beam diameter (dots)	7x7
9x9	7x7
9x9
Fluence	25 mJ/dot (7x7 mm)
13 mJ/dot (9x9 mm)	25 mJ/dot (7x7 mm)
13 mJ/dot (9x9 mm)
Emission frequency	Up to 1,5 Hz	Up to 1,5 Hz
Intended Use	The Er:Yag Fractional tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue,
striated and smooth tissue, muscle, cartilage meniscus, mucous
membrane, lymph vessels and nodes; organs, and
glands) such as, but not limited to:
*Dermatology and plastic Surgery: Skin resurfacing3 Treatment
of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic
chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar
revision (including acne scars).	Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue,
striated and smooth tissue, muscle, cartilage meniscus,
mucous membrane, lymph vessels and nodes; organs, and
glands) such as, but not limited to:
*Dermatology and plastic Surgery: Skin resurfacing3
Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider
veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags;
Keratoses: Scar revision (including acne scars):

23

G)Er:Yag Glass Handpiece

Applicant	BIOS	PALOMAR	Applicant	BIOS	BIOS	ALMA
Device Name	SUPERBIUM	LUX 1540	Device Name	SUPERBIUM	APL MEDICAL SYSTEM	HARMONY XL
510k	K153229	K090195	510k	---	K072344	K072564
Classification	GEX 21 CFR 878.4810,
ONF 21 CFR 878.4810	GEX	Classification	GEX 21 CFR 878.4810,
ONF 21 CFR 878.4810	GEX, FTC	GEX, FTC, HHR, LNK
Laser source	Er:Glass	Er:Glass	Source	Pulsed light Xenon lamp	Pulsed light Xenon lamp	Pulsed light fluorescence lamp
Wavelenght	1540 nm	1540 nm	Emission spectrum	400 – 1.200 nm	400 – 1.000 nm	420 – 950 nm
Max energy per pulse	10 J	10 J	Spot dimension	1; 3; 5; 8 cm2	8 cm2	3; 6 cm2
Dot Density (Dot/cm²)	100; 320	100; 320	Standard filters	500-550-580-620-755 nm	530; 550; 580; 620 nm	420; 515; 540; 570; 780 nm
Fluence	100mJ/dot (max) (100 dots)
31mJ/dot (max) (320 dots)	100mJ/dot (max) (100 dots)
31mJ/dot (max) (320 dots)	Max energy per pulse	200 J	250 J	180 J
Pulse duration	Up to 15 ms	Up to 15 ms	Fluence (max)	30 J/cm2	30 J/cm2	30 J/cm2
Emission frequency	Up to 1,5 Hz	Up to 1,5 Hz	Pulse duration (max)	From 1 to 20 ms	5 - 50 ms	10 - 50 ms
Intended Use	The Er:Yag Glass 1540 nm Fractional Laser Handpiece is intended for use in:
coagulation of soft tissue, skin resurfacing procedures
as well as treatment of melasma, striae, acne scars and surgical scars.	The Palomar Lux1540 Handpiece is intended for use in:
Coagulation of soft tissue;
Skin resurfacing procedures;
Treatment of melasma and striae; Treatment of acne scars and surgical scars.	Emission frequency
(max)	1 Hz	1 Hz	2 - 4 Hz
Pause between one
pulse train and the
next	From 5 to 500 ms	From 5 to 100 ms	-
Intended Use	IPL 400-1200 nm handpiece is indicated
for:

The treatment of moderate
inflammatory acne vulgaris.
· The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, inelasma, and
ephelides (freckles).
· The treatment of cutaneous lesions
including warts, scars and striae.
· The treatment of benign cutaneous
vascular lesions including port wine
stains, hemangiomas, facial, truncal and
leg telangiectasias, rosacea, erythema
of rosacea, angiomas and spider | | 420-950 nm Acne Module AFT Handpiece
The Advanced Fluorescence Technology
(AFT) 420-950 nm Acne Module handpiece
(with and without contact-cooling) is
indicated for:
The treatment of moderate
inflammatory acne vulgaris.
· The treatment of benign pigmented
epidermal lesions including dyschromia,
hlyperpigmentation, inelasma, and
ephelides (freckles).
· The treatment of cutaneous lesions
including warts, scars and striae.
· The treatment of benign cutaneous
vascular lesions including port wine stains, | | | |

24

Bios s.r.l.
rev.03 pag. 19 of 26

H)IPL Handpiece

25

Section V

Bios s.r.l. rev.03

pag. 20 of 26

Applicant	BIOS	BIOS	ALMA
Device Name	SUPERBIUM	APL MEDICAL SYSTEM	HARMONY XL
510k	---	K072344	K072564
	angiomas, poikiloderma of Civatte, leg
veins and venous malformations.
· Use on all skin types (Fitzpatrick I-VI).		hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations.
· Use on all skin types (Fitzpatrick I-VI).
	IPL 500-1200 nm handpiece is indicated
for:
· The treatment of moderate
inflammatory acne (acne vulgaris).

The treatment of tattoos and benign
pigmented epidermal and cutaneous
lesions including warts, scars, striae,
dyschromia, hyperpigmentation,
melasma, ephelides (freckles),
lentigines, nevi, melasma, and cafè-au-
lait macules.
The treatment of benign cutaneous
vascular lesions including port wine
stains, hemangiomas, facial, truncal and
leg telangiectasias, rosacea, erythema
of rosacea,
angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations.
· The removal of unwanted hair to effect
stable long-term or permanent hair
reduction.
· Use on Fitzpatrick skin types I-V. | | 515-950 nm SV515 & SVL515 Module AFT
Handpieces
The Advanced Fluorescence Technology
(AFT) 515-950 nm VL515 and SVL515
Module handpieces (with and without
contact-cooling) are indicated for:
· The treatment of moderate inflammatory
acne (acne vulgaris).
The treatment of tattoos and benign
pigmented epidermal and cutaneous
lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma,
ephelides (freckles), lentigines, nevi,
melasma, and cafè-au-lait macules.
The treatment of benign cutaneous
vascular lesions including port wine stains,
hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations.
· The removal of unwanted hair to effect
stable long-term or permanent hair
reduction. |
| Applicant | BIOS | BIOS | ALMA |
| Device Name | SUPERBIUM | APL MEDICAL SYSTEM | HARMONY XL |
| 510k | --- | K072344 | K072564 |
| | IPL 550-1200 nm handpiece is indicated
for: | | 540-950 nm VL/PL, VP, and SSR Module |
| | · The treatment of moderate | | AFT Handpieces |
| | inflammatory acne vulgaris. | | The Advanced Fluorescence Technology |
| | · The treatment of benign pigmented | | (AFT) 540-950 nm VL/PL, VP, and SSR |
| | epidermal lesions including dyschromia, | | Module |
| | hyperpigmentation, melasma, and | | handpieces (with and without contact- |
| | ephelides (freckles), lentigines, nevi, | | cooling) are indicated for: |
| | melasma, and | | · The treatment of moderate inflammatory |
| | cafè-au-lait macules. | | acne vulgaris. |
| | * The treatment of cutaneous lesions | | · The treatment of benign pigmented |
| | including warts, scars and striae. | | epidermal lesions including dyschromia, |
| | · The treatment of benign cutaneous | | hyperpigmentation, melasma, and |
| | vascular lesions including port wine | | ephelides (freckles), lentigines, nevi, |
| | stains, hemangiomas, facial, truncal and | | melasma, and |
| | leg telangiectasias, rosacea, erythema | | cafè-au-lait macules. |
| | of rosacea, angiomas and spider | | * The treatment of cutaneous lesions |
| | angiomas, poikiloderma of Civatte, leg | | including warts, scars and striae. |
| | veins and venous malformations. | | · The treatment of benign cutaneous |
| | * The removal of unwanted hair to | | vascular lesions including port wine stains, |
| | effect stable long-term or permanent | | hemangiomas, facial, truncal and leg |
| | hair reduction. | | telangiectasias, rosacea, erythema of |
| | : Use on all skin types (Fitzpatrick I-VI). | | rosacea, angiomas and spider angiomas, |
| | | | poikiloderma of Civatte, leg veins and |
| | | | venous malformations. |
| | | | * The removal of unwanted hair to effect |
| | | | stable long-term or permanent hair |
| | | | reduction. |
| | | | : Use on all skin types (Fitzpatrick I-VI). |
| Applicant | BIOS | BIOS | ALMA |
| Device Name | SUPERBIUM | APL MEDICAL SYSTEM | HARMONY XL |
| 510k | --- | K072344 | K072564 |
| | 580-1200 nm handpiece is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
The treatment of face and body vascular and pigmented lesions.
The treatment of cutaneous lesions, including scars and striae.
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
The removal of unwanted hair to effect stable long-term or permanent hair reduction.
• Use on all skin types (Fitzpatrick I-VI). | | 570-950 nm SR Module AFT Handpiece
The Advanced Fluorescence Technology (AFT) 570-950 nm SR Module handpiece (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
The treatment of face and body vascular and pigmented lesions.
The treatment of cutaneous lesions, including scars and striae.
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
The removal of unwanted hair to effect stable long-term or permanent hair reduction.
• Use on all skin types (Fitzpatrick I-VI). |
| Applicant | BIOS | BIOS | ALMA |
| Device Name | SUPERBIUM | APL MEDICAL SYSTEM | HARMONY XL |
| 510k | --- | K072344 | K072564 |
| | IPL 620-1200 nm handpiece is indicated
for:
The treatment of tattoos.
The treatment of moderate
inflammatory acne vulgaris.
The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, melasma, and
ephelides (freckles), lentigines, nevi,
melasma, and cafè-au-lait.
• The treatment of cutaneous lesions
including warts, scars and striae.
The treatment of benign cutaneous
vascular lesions including port wine
stains, hemangiomas, facial, truncal and
leg telangiectasias, rosacea, erythema
of rosacea, angiomas and spider
angiomas, poikiloderma of Civatte, leg
veins and venous malformations.
: The removal of unwanted hair and to
effect stable long-term or permanent
hair reduction.
• Use on all skin types (Fitzpatrick I-VI),
including tanned skin. | 1. The removal of unwanted
hair and to effect stable long-
term or permanent hair
reduction | 650-950 nm HR Module AFT Handpiece
The Advanced Fluorescence Technology
(AFT) 650-950 nm HR Module handpiece
(with and without contact-cooling) is
indicated for:
The treatment of tattoos.
The treatment of moderate
inflammatory acne vulgaris.
The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, melasma, and
ephelides (freckles), lentigines, nevi,
melasma, and cafè-au-lait.
• The treatment of cutaneous lesions
including warts, scars and striae.
The treatment of benign cutaneous
vascular lesions including port wine stains,
hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations.
: The removal of unwanted hair and to
effect stable long-term or permanent hair
reduction.
• Use on all skin types (Fitzpatrick I-VI), |
| Applicant | BIOS | BIOS | ALMA |
| Device Name | SUPERBIUM | APL MEDICAL SYSTEM | HARMONY XL |
| 510k | --- | K072344 | K072564 |
| | 755-1200 nm handpiece is indicated
for:
The treatment of tattoos.
The treatment of moderate
inflammatory acne vulgaris.
The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, melasma, and
ephelides (freckles).
: The treatment of cutaneous lesions
including warts, scars and striae.
The treatment of benign cutaneous
vascular lesions including port wine
stains, hemangiomas, facial, truncal and
leg telangiectasias, rosacea, erythema
of rosacea, angiomas and spider
angiomas, poikiloderma of Civatte, leg
veins and venous malformations.
The treatment of psoriasis, vitiligo,
atopic dermatitis (eczema), seborrheic
dermatitis.
The treatment of pseudofolliculitis
barbae (PFB).
The removal of unwanted hair to effect
stable long-term or permanent hair
reduction
Use on all skin types (Fitzpatrick I-VI),
including tanned skin. | 4. The non-ablative treatment
of facial wrinkles, such as, but
not limited to:
Periocular wrinkles
Perioral wrinkles

Treatment of vitiligo and
psoriasis | 780-950 nm SST AFT Module Handpiece
The Advanced Fluorescence Technology
(AFT) 780-950 nm SST Module handpiece
(with contact-cooling) is indicated for:

The treatment of tattoos.
The treatment of moderate
inflammatory acne vulgaris.
The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, melasma, and
ephelides (freckles).
: The treatment of cutaneous lesions
including warts, scars and striae.
The treatment of benign cutaneous
vascular lesions including port wine stains,
hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations.
The treatment of psoriasis, vitiligo,
atopic dermatitis (eczema), seborrheic
dermatitis.
The treatment of pseudofolliculitis
barbae (PFB).
The removal of unwanted hair to effect
stable long-term or permanent hair
reduction
Use on all skin types (Fitzpatrick I-VI),
including tanned skin. |

26

Section V

Bios s.r.l.
rev.03

pag. 21 of 26

27

Section V

pag. 22 of 26

28

Section V

Bios s.r.l.
rev.03

pag. 23 of 26

29

Section V

Bios s.r.l.

rev.03

pag. 24 of 26

30

Performance data VII.

Biocompatibility testing

SUPERBIUM is classified as a surface device (≤ 24 hours contact duration) in contact with skin in accordance with ISO 10993.

The patient contacting materials for the device and accessories are all well known for their compatibility.

Electrical safety and EMC

The SUPERBIUM has been tested and is in compliance with:

EN 60601-1, Medical electrical equipment. Part 1: General requirements for basic safety and essential । performance 2006/A11:2010/A1:2013, EN 60601-2-22:2013 Medical electrical equipment;
EN60601-1-2 Medical electrical equipment. Part1: General requirements for safety - Collateral standard: Electromagnetic Compatibility - Requirements and tests.

Software verification and validation testing

Software verification and validation was conducted according to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements.

Usability testing

Usability of the SUPERBIUM have been tested in accordance with the standard EN 60601-1-6:2010

Pre series test

Pre-series tests (see attachment 15 D) have been performed to support the evidence that performances of SUPERBIUM are aligned with the identified intended uses.

Animal and clinical study

Animal and clinical studies were not necessary to demonstrate that the permormances are comparable to the predicate devices.

31

510(k) Premarket Notification	Bios s.r.l.
SUPERBIUM	rev.03
Section V	pag. 26 of 26

VIII. Conclusions

BIOS s.r.l. has determined, by using comparisons and tests, thta SUPERBIUM is substantially equivalent to the listed predicate devices in terms of intended use, typical clinical use, operational characteristics, and fundamental technological characteristics. Any differences are considered minor and do not raise new issues of the safety and effectiveness of the SUPERBIUM device when compared to the predicate devices.