The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery. Specific indications include treatment of benign vascular lesions, benign pigmented lesions, hair removal, tattoo removal, skin resurfacing for acne scars and wrinkles, photocoagulation and hemostasis of benign pigmented and benign vascular lesions, coagulation and hemostasis of soft tissue, treatment of wrinkles, and treatment of mild to moderate inflammatory acne vulgaris.

Device Description

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The systems can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces or a handpiece (Twain IPL) with fixed or interchangeable light filters. All models have the same components and control software, differing only in the installed optical bench. The device is controlled via a touch screen display and emission is triggered by a footswitch.

AI/ML Overview

The provided FDA 510(k) summary for the Discovery Pico Family laser system focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for clinical efficacy through a standalone study.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document. The document primarily relies on engineering performance standards and a comparative analysis with predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., specific percentages of tattoo clearance or lesion removal). Instead, it states compliance with recognized engineering performance standards and "thermal-histology performance data for fractional handpieces." It also asserts that "the device performs as intended" and is "substantially equivalent to the predicate devices."

Acceptance Criteria (Explicit Clinical Performance)	Reported Device Performance
Not explicitly defined in terms of clinical outcomes (e.g., % tattoo clearance, % lesion reduction). The document focuses on engineering and safety standards.	"The Discovery Pico Family is substantially equivalent to the predicate devices."
Engineering Performance Standards:	Compliance with:
- IEC 60601-2-22 (Surgical Laser Equipment)	Met
- IEC 60825-1 (Safety of Laser Products)	Met
- IEC 60601-1 (General Electrical Safety)	Met
- IEC 60601-1-2 (Electromagnetic Compatibility)	Met
Thermal-histology performance data for fractional handpieces:	Data exists (details not provided in this summary).
Software Verification and Validation:	Conducted and documented per FDA guidance.
Biocompatibility:	Established based on predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set with human subjects for efficacy evaluation beyond what might be implied by "thermal-histology performance data."
Data Provenance: Not applicable/Not provided for clinical efficacy. The engineering standards compliance refers to internal company testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of a ground truth established by experts for clinical performance, as the submission focuses on substantial equivalence based on technical characteristics and predicate devices, rather than a clinical trial with a defined ground truth.

4. Adjudication Method

Not applicable. No clinical study with a read-out or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not done, as this is a laser device and not an imaging AI diagnostic tool that would typically involve multiple readers. The document implicitly compares the new device's capabilities to predicate devices, but not in a formal MRMC study format.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical laser device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The device's standalone performance is assessed through its compliance with engineering standards.

7. The Type of Ground Truth Used

The ground truth used for relevant aspects where data is mentioned would be:
- Engineering Standards: Compliance with established safety and performance requirements set by IEC standards.
- Thermal-histology data: This would typically involve histological analysis of treated tissue in an experimental setting (e.g., animal or ex vivo human tissue) to assess the thermal impact, which serves as a form of ground truth for tissue response. Details are not provided.
- Biocompatibility: Established by reference to predicate device characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is used for this type of medical device submission.

Summary

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October 19, 2017

Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs & Quality Assurance Via Acquedotto, 109 Samarate, VA 20826, IT

Re: K172376

Trade/Device Name: Discovery Pico Family 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 Dated: October 17, 2017 Received: August 7, 2017

Dear Francesco Dell'antonio:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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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 (DICE) 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 (DICE) 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,

Jennifer R. Stevenson -S3

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172376

Device Name Discovery Pico Family

Indications for Use (Describe) General intended use

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode)

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

port wine birthmarks
telangiectasias
spider angiomaa
Cherry angioma
Spider nevi
Treatment of benign pigmented lesions including, but not limited to:
cafe-au-Iait birthmarks
Ephalides, solar lentigines
senile lentigines
Becker's nevi
freckles
common nevi
nevus spilus
Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode)

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

nevus of Ota
Café au lait spot
Ephalides, solar lentigo (lentigines)
Becker Nevus
Nevus spilus
Treatment of common nevi

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Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode) . also with fractional handpiece

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-V

1064 nm (picosecond mode), also with fractional handpiece

Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V

694 nm (Q-Switched)

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink

Pigmented lesion removal (benign):

Cafe au lait spot
Ephalides, solar lentigo lentigines)
Becker Nevus
Ota and Ito Nevus
Nevus spilus
Mongolian spot

694 nm (non q-switch - free running mode)

Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction 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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

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IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	16th October , 2017
Device Name:	Discovery Pico Family
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Primary predicate device	Discovery Pico Family (K171945), Quanta System SpA
Reference predicate device	PicoWay Laser System (K170597), SYNERON CANDELACORPORATION

The modified device Discovery Pico Family is derived from the legally marketed (unmodified) device Discovery Pico Family (K171945).

Performance Standards:

There are no mandatory performance standards for this device.

Description of the device (unchanged from K171945):

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser) The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

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The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed.

The Discovery Pico Family is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Intended use

The intended use and the indications for use of the modified device and the unmodified device are exactly the same, as follows.

General intended use

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode)

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:

י port wine birthmarks
י telangiectasias
spider angiomaa
-Cherry angioma
-Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

cafe-au-lait birthmarks
Ephalides, solar lentigines l
senile lentigines
-Becker's nevi
freckles
common nevi

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י nevus spilus
Ota Nevus ।

Treatment of seborrheic keratosis Treatment of post inflammatory hyperpigmentation Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode)

Removal of dark ink (black, blue and brown) tattoos Removal of benign pigmented lesions including;

nevus of Ota ı
Café au lait spot ।
। Ephalides, solar lentigo (lentigines)
-Becker Nevus
i Nevus spilus

Treatment of common nevi Removal or lightening of unwanted hair Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode) , also with fractional handpiece

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-V

1064 nm (picosecond mode), also with fractional handpiece

Indicated for the removal of tattoos for all skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-V Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V

694 nm (Q-Switched)

Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign):

i Cafe au lait spot

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-Ephalides, solar lentigo lentigines)
-Becker Nevus
-Ota and Ito Nevus
-Nevus spilus
-Mongolian spot

694 nm (non q-switch – free running mode)

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction 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

IPL 550-1200nm; 570-1200nm

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

Performance data:

Discovery Pico family devices comply with the following recognized consensus standards:

IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment Part 2-22: Particular . Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
. IEC 60825-1 Edition 3.0: 2014, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
. IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

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. IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
. Thermal-histology performance data for fractional handpieces

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Biocompatibility:

The biocompatibility of the Discovery Pico Family is established based on the predicate devices.

Comparison with predicate device:

The subject device and primary predicate have comparable general intended use and technological characteristics. Expanded specific indications for use for the fractional handpieces are supported by comparable technological specification within the subject device and the reference predicate.

Any minor differences do not present any new types of safety or effectiveness questions since the Discovery Pico Family parameters are similar to or within the range of the predicates.

Summary

Testing of the Discovery Pico Family demonstrated that the device performs as intended. The Discovery Pico Family is substantially equivalent to the predicate devices.

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.