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 vascular lesions, and for hair, tattoo removal and the incision, excision, 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 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

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 pigmented and 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.

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.

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 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 (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 vascular lesion, 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. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Discovery Pico Family laser system, which describes its modifications and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance metrics, or a study design in the way typically expected for a clinical validation or AI-based device. Instead, it focuses on regulatory compliance and the safety/effectiveness of a modified laser device.

However, I can extract the relevant information that is present in the document which aligns with some of your requested categories, and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "There are no mandatory performance standards for this device." Instead of specific numerical acceptance criteria for clinical performance, the approval is based on compliance with electrical and safety standards, and equivalence to predicate devices.

Acceptance Criterion (Compliance)	Reported Device Performance (Compliance Status)
IEC 60601-2-22: Surgical Laser Equipment	Complies
IEC 60825-1: Laser Product Safety	Complies
IEC 60601-1: Medical Electrical Equipment	Complies
IEC 60601-1-2: Electromagnetic Compatibility	Complies
Software Verification and Validation Testing	Conducted and documentation provided
Biocompatibility of materials	Established based on predicate devices
Thermal-histology performance (fractional handpieces)	Data provided (details not in summary)

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

Not applicable. This document describes a medical device clearance based on substantial equivalence and compliance with engineering standards, not a clinical study involving a test set of data. The "test set" in this context refers to engineering and safety performance tests of the device itself, not a dataset for evaluating an algorithm's diagnostic or predictive performance.

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

Not applicable. (See explanation for point 2).

4. Adjudication method for the test set

Not applicable. (See explanation for point 2).

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

Not applicable. This is not an AI-based diagnostic or imaging device. It is a laser surgical instrument.

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

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used

For the engineering and safety performance tests mentioned, the "ground truth" would be established by validated test methods and measurements against established engineering and safety standards. For example, laser power output would be measured with calibrated equipment, and electrical safety would be verified according to IEC standards.

8. The sample size for the training set

Not applicable. (See explanation for point 2).

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

Not applicable. (See explanation for point 2).

Summary of Study (Based on the provided document):

The "study" described in this 510(k) summary is a regulatory submission demonstrating the substantial equivalence of the modified Discovery Pico Family laser system to previously cleared predicate devices. The primary focus is on proving that the modified device (with added fractional handpieces) maintains the same intended use, indications for use, and fundamental scientific technology as its unmodified predecessor (K163222), and that any differences do not raise new questions of safety or effectiveness.

The document highlights compliance with several recognized consensus standards (IEC 60601-2-22, IEC 60825-1, IEC 60601-1, IEC 60601-1-2) which cover general safety, laser safety, and electromagnetic compatibility for medical electrical equipment. It also mentions "Thermal-histology performance data for fractional handpieces" as being provided, which would involve laboratory/bench testing. Software verification and validation testing were also conducted.

There is no mention of clinical trials, human reader studies, or AI algorithm performance evaluations because the device is a laser system whose safety and effectiveness are established through compliance with existing standards and comparison to legally marketed predicate devices, rather than through novel diagnostic performance.

Summary

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, one behind the other. The seal is in black and white.

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

July 28, 2017

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

Re: K171945

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 26, 2017 Received: June 28, 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 Actinclude 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

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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 the quality systems (OS) 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.

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) K171945

Device Name Discovery Pico Family

Indications for Use (Describe) General intended use

Indications for use

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

532 nm (Q-Switched, nanosecond mode)

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

Treatment of 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

{3}------------------------------------------------

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 pigmented and 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.

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.

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)

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

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Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:	July 27th , 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 (K163222), Quanta System SpA
Reference predicate device	PicoWay Laser System (K162454), SYNERON CANDELACORPORATION

The modified device Discovery Pico Family is derived from the legally marketed (unmodified) device Discovery Pico Family (K163222).

Performance Standards:

There are no mandatory performance standards for this device.

Description of the device:

The Description of the modified device and the unmodified device are exactly the same:

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)

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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.

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.

Description of the modifications:

The difference between the modified and unmodified devices is limited to the addition of two fractional handpieces.

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 vascular lesions, 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 vascular lesions including, but not limited to:

। port wine birthmarks
י telangiectasias
spider angiomaa

{7}------------------------------------------------

Cherry angioma -
Spider nevi -

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

cafe-au-lait 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

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 pigmented and 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.

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.

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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)

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 (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

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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
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 materials of the modified and unmodified device have no differences.

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

Conclusion:

The modified Discovery Pico Family has the same intended use, the same indications for use and the same fundamental scientific technology as the unmodified Discovery Pico Family (K163222).

The performance specifications of modified Discovery Pico Family are the unmodified Discovery Pico Family (K163222), except for the addition of two fractional handpieces. A reference predicate device was considered for the fractional handpieces, K162454, that has equivalent performances and intended use so that there are no different questions of safety and effectiveness.

Therefore, the Discovery Pico Family is substantially equivalent to its identified 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.