K Number
K072344
Device Name
APL MEDICAL SYSTEM
Manufacturer
Date Cleared
2007-12-03

(104 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications. It is used to treat common imperfections and lesions of skin and body , including: - 1. The removal of unwanted hair and to effect stable long-term or permanent hair reduction - 2. Laser skin treatment procedures for the treatment of: - Acne scars . - Wrinkles . - 3. Incision, excision, ablation, vaporization of soft tissue - The non-ablative treatment of facial wrinkles, such as, but not limited to: 4. - Periocular wrinkles . - . Perioral wrinkles - 5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions - 6. Treatment of capillaries, teleangiectasies and vascular lesions - 7. Treatment of vitiligo and psoriasis
Device Description
The portable device APL MEDICAL SYSTEM, is a multi-laser and pulsed light system, designated to act on the most diffused imperfections of the skin and body. The equipmentm is conceived as an expandable system for the field of aesthetic medicine, composed of a modular platform, containing the entire electronics of the system and the cooling circuit, and a series of interchangeable hand pieces to be connected on the platform, finalized to treat specific groups of imperfections. A rapid connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following hand pieces are available: 1) Hand piece Pulsed Light. With the use of this hand piece the removal of unwanted hair is extremely quick and efficient, as it is possible to treat large areas (up to 9 cm2) using a single pulse or "burst" mode This system is effective on varius skin types. On this hand piece 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. Furthermore, it is possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues. 2) Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs. 3) Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse. 4) Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.
More Information

Not Found

No
The summary describes a multi-laser and pulsed light system for aesthetic and surgical applications. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies. The device description focuses on the hardware components and their intended uses based on different wavelengths and pulse types.

Yes.
The device is intended to treat various medical conditions and imperfections of the skin and body, which falls under the definition of a therapeutic device.

No

The device is described as a multi-laser and multi-use device for aesthetic, cosmetic, and surgical applications, focused on treating imperfections and lesions. Its functions are therapeutic (e.g., hair removal, skin treatment, incision, tattoo removal), not diagnostic.

No

The device description clearly states it is a "modular multi-laser and pulsed light system" with "interchangeable hand pieces" and a "modular platform, containing the entire electronics of the system and the cooling circuit." This indicates a physical hardware device, not software only.

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

Here's why:

  • Intended Use: The intended use clearly states that the device is for "aesthetic, cosmetic, and surgical applications" and is used to "treat common imperfections and lesions of skin and body." This involves direct interaction with the patient's body for therapeutic purposes.
  • Device Description: The description details a multi-laser and pulsed light system with interchangeable hand pieces designed to act on the skin and body. This is consistent with a device used for external treatments.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The APL MEDICAL SYSTEM does not perform any such analysis of biological specimens.

The APL MEDICAL SYSTEM is a medical device used for therapeutic and aesthetic procedures performed directly on the patient's body.

N/A

Intended Use / Indications for Use

The APL MEDICAL SYSTEM is indicate for: removal of unwanted hair and to effect stable long-term or permanent hair reduction; laser skin procedures for the treatment of acne scars and wrinkles; incision, excision, ablation, vaporization of soft tissue; non-ablative treatment of facial wrinkles, such as, but not limited to periocular wrinkles and perioral wrinkles: removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions, treatment of capillaries, teleangiectasies and vascular lesions, the treatment of vitiligo and psoriasis.

The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications.

It is used to treat common imperfections and lesions of skin and body , including:

  1. The removal of unwanted hair and to effect stable long-term or permanent hair reduction
  2. Laser skin treatment procedures for the treatment of:
    Acne scars.
    Wrinkles.
  3. Incision, excision, ablation, vaporization of soft tissue
  4. The non-ablative treatment of facial wrinkles, such as, but not limited to:
    Periocular wrinkles.
    . Perioral wrinkles
  5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
  6. Treatment of capillaries, teleangiectasies and vascular lesions
  7. Treatment of vitiligo and psoriasis

Product codes

GEX, FTC

Device Description

The portable device APL MEDICAL SYSTEM, is a multi-laser and pulsed light system, designated to act on the most diffused imperfections of the skin and body. The equipmentm is conceived as an expandable system for the field of aesthetic medicine, composed of a modular platform, containing the entire electronics of the system and the cooling circuit, and a series of interchangeable hand pieces to be connected on the platform, finalized to treat specific groups of imperfections. A rapid connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following hand pieces are available:

  1. Hand piece Pulsed Light. With the use of this hand piece the removal of unwanted hair is extremely quick and efficient, as it is possible to treat large areas (up to 9 cm2) using a single pulse or "burst" mode This system is effective on varius skin types. On this hand piece 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. Furthermore, it is possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues.
  2. Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs.
  3. Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse.
  4. Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin and body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Under medical supervision.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data: None
Clinical Performance Data: None

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K042000, K033946

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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K 072344

510(k) SUMMARY

| Submitter: | Bios Italia s.r.l.
Via Guido Rossa, 10/12
20090 Vimodrone (MI) - Italy | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Aldo Casalino | DEC 03 2007 |
| Date Summary Prepared: | June 27, 2007 | |
| Device Trade Name: | APL MEDICAL SYSTEM | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser
GEX and FTC
21 CFR 878.4810 and 21 CFR 878.4630 | |
| Equivalent Device: | MSq(M2) LTD - Lovely System (K042000 and K033946) | |
| Device Description: | The portable device APL MEDICAL SYSTEM, is a multi-
laser and pulsed light system, designated to act on the most
diffused imperfections of the skin and body. The
equipmentm is conceived as an expandable system for the
field of aesthetic medicine, composed of a modular
platform, containing the entire electronics of the system and
the cooling circuit, and a series of interchangeable hand
pieces to be connected on the platform, finalized to treat
specific groups of imperfections. A rapid connection
enables the quick and easy replacement of the various hand
pieces that can be mounted on the modular platform. The
following hand pieces are available: | |
| | 1) Hand piece Pulsed Light. With the use of this hand piece
the removal of unwanted hair is extremely quick and
efficient, as it is possible to treat large areas (up to 9
cm2) using a single pulse or "burst" mode This system
is effective on varius skin types. On this hand piece 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. Furthermore, it is | |

1

possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues.

    1. Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs.
    1. Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse.
    1. Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.

The APL MEDICAL SYSTEM is indicate for: removal of Intended Use: unwanted hair and to effect stable long-term or permanent hair reduction; laser skin procedures for the treatment of acne scars and wrinkles; incision, excision, ablation, vaporization of soft tissue; non-ablative treatment of facial wrinkles, such as, but not limited to periocular wrinkles and perioral wrinkles: removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions, treatment of capillaries, teleangiectasies and vascular lesions, the treatment of vitiligo and psoriasis.

2

| Rationale for Substancial
Equivalence: | The product specification, functionality, indication for use,
and treatment parameters of the APL MEDICAL SYSTEM
are the same or very similar to the legally marketed laser
MSq(M2) LTD - Lovely System Model: Lovely II
Harmony. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Both systems have the same indication for use. |
| | Both systems comprise a flashlamp pumped laser rod
(Nd:YAG) generating light at a wavelength of 1064 nm,
which is subsequently delivered to the patient via an optical
fiber delivery system, and focusing handpiece. |
| | The APL MEDICAL SYSTEM output characteristics
(including pulse duration and fluence) are identical, or very
similar, to those of the predicate device. |
| | Both lasers utilize class IIIA aiming beams. |
| | Both lasers are microprocessor controlled devices. |
| | Both systems utilize an internal closed loop water-air heath
exchanger circuit for optimal thermal control of laser cavity |
| | The risks and benefits for the APL MEDICAL SYSTEM are
comparable to those for the predicate device. Therefore, the
introduction of this laser should not raise new questions of
Safety and Effectiveness . |

.

Non-Clinical Performance Data: None

Clinical Performance Data: None

:

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2007

Bios Italia s.r. % Mr. Aldo Casalino General Manager Via Guido Rossa, 10/12 Vinodrone (Milan) MI I-20090 Italy

Re: K072344 Trade/Device Name: APL Medical System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, FTC Dated: November 8, 2007 Received: November 27, 2007

Dear Mr. Casalino:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

4

Page 2 - Mr. Aldo Casalino

forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Mullman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

INDICATION FOR USE STATEMENT

510(k) Number (if known): K072344

Device Name: APL MEDICAL SYSTEM

Sponsor Name: Bios Italia s.r.l.

Indication for Use:

The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications.

It is used to treat common imperfections and lesions of skin and body , including:

    1. The removal of unwanted hair and to effect stable long-term or permanent hair reduction
    1. Laser skin treatment procedures for the treatment of:
    • Acne scars .
    • Wrinkles .
    1. Incision, excision, ablation, vaporization of soft tissue
  • The non-ablative treatment of facial wrinkles, such as, but not limited to: 4.
    • Periocular wrinkles .
    • . Perioral wrinkles
    1. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
    1. Treatment of capillaries, teleangiectasies and vascular lesions
    1. Treatment of vitiligo and psoriasis

The equipment should only be used under medical supervision.

Do Not Write Below This Line – Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Over-The-Counter Use

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number: k6723449