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 as follows.

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), including microbeam handpieces:

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), including microbeam handpieces:

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

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 and microbeam handpieces:

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-IV

1064 nm (picosecond mode), also with fractional and microbeam handpieces:

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 (O-Switched), including microbeam handpieces

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 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.

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 lesson, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

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 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.

lt can also be connected to Er:YAG handpieces cleared under K173002.

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 controlling 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.

AI/ML Overview

The provided text is a 510(k) summary for the Discovery Pico Family laser device, submitted to the FDA. It details a modification to an already cleared device, primarily the addition of microbeam handpieces. As such, the acceptance criteria and performance data presented are focused on engineering and safety performance, rather than clinical efficacy or diagnostic accuracy as would be the case for an AI/ML-driven diagnostic device.

Therefore, many of the requested fields related to clinical studies, human reader performance, ground truth establishment for clinical data, and training set information are not applicable to this type of device submission.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Measured against recognized consensus standards)	Reported Device Performance
Electrical safety (IEC 60601-2-22, IEC 60601-1)	Device underwent and successfully passed electrical safety testing.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Device underwent and successfully passed EMC testing.
Performance Testing (Output of newly added microbeam handpieces)	Bench testing measurements were done to confirm the output of microbeam handpieces.
Software Verification and Validation (FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")	Software verification and validation testing were conducted and documentation was provided as recommended by FDA guidance.
Biocompatibility	Established based on the predicate devices (K172376).
Safety of Laser Products (IEC 60825-1)	Device complies with IEC 60825-1 Edition 3.0: 2014, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements.
Overall Performance Claim:	"Testing of the Discovery Pico Family demonstrated that the device performs as intended. The Discovery Pico Family is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance:

Not applicable / Not specified. The performance data described are related to engineering and safety bench tests (e.g., electrical safety, EMC, output measurements on microbeam handpieces) and software validation. These do not typically involve patient-specific test sets in the same way clinical diagnostic studies do. The phrase "Bench testing measurements were done" implies testing on physical units/components, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. For engineering and safety tests, the "ground truth" is typically established by objective measurements against predefined specifications and recognized standards, not by expert human interpretation of clinical data.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a clinical study. This device's testing involves objective measurements against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted diagnostic device, but a physical laser device for surgical and aesthetic applications. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical laser device, not an algorithm. The software verification and validation are for controlling the device, not for making independent diagnostic or therapeutic decisions.

7. The type of ground truth used:

For electrical safety, EMC, and laser safety: Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1).
For microbeam handpiece output: Physical bench measurements to confirm output against design specifications.
For software: Verification and validation against software requirements as per FDA guidance.
For biocompatibility: Reference to the predicate device.

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. No training set was used for an AI/ML algorithm.

Summary

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September 17, 2019

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

Re: K191842

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: June 27, 2019 Received: July 9, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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542 of the Act); 21 CFR 1000-1050.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K191842

Device Name Discovery Pico Family

Indications for Use (Describe) General intended use