2940 nm Er:Yag Laser Handpiece

K173002 · Quanta System Spa · GEX · Dec 13, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K173002
• Device Name: 2940 nm Er:Yag Laser Handpiece
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) 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). With microbeam end piece it is indicated for Skin resurfacing.

Device Story

2940 nm Er:YAG laser handpiece; accessory for Quanta System laser platforms (Quanta Forte, EVO, Discovery Pico). Delivers 2940 nm laser energy to soft tissue; includes optional microbeam end piece for skin resurfacing. Operated by physician in clinical setting; triggered via footswitch connected to host console. Host console recognizes handpiece and controls emission parameters. Output used for dermatological and plastic surgery procedures; enables precise tissue ablation and resurfacing. Benefits include improved skin texture and scar appearance.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety, EMC, and histological performance data demonstrating equivalent skin resurfacing effects to predicate devices with microlens arrays.

Technological Characteristics

Er:YAG laser handpiece; 2940 nm wavelength; max energy 3J; pulse duration 0.3-1.5 ms; max repetition rate 6 Hz. Spot sizes: 2, 4, 9 mm and 9 mm dots array. Connects to Quanta System consoles for control. Complies with IEC 60601-1, IEC 60601-2-22, and IEC 60601-1-2. Biocompatibility established via predicate devices.

Indications for Use

Indicated for soft tissue (skin and cutaneous tissue) procedures including skin resurfacing, wrinkle treatment, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, and scar revision (including acne scars).

Regulatory Classification

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.

Predicate Devices

• Quanta Forte (K152714)
• FOTONA F-22 LASER HANDPIECE, FOTONA FS-01 LASER HANDPIECE (K132806)
• MicroSpot Handpiece (K152153)

Submission Summary (Full Text)

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December 13, 2017

Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs and Quality Assurance Via Acquedotto, 109 Samarate, IT 21017 VA

Re: K173002

Trade/Device Name: 2940 nm Er: Yag Laser Handpiece 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: September 18, 2017 Received: September 27, 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, 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 (QS) 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -53

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) K173002

Device Name 2940 nm Er: Yag Laser Handpiece

2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) 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).

With microbeam end piece it is indicated for Skin resurfacing.

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

## Introduction:

This document contains the 510(k) Summary for the 2940 nm Er:YAG handpiece. The content of this summary is based on the requirements of 21 CFR 807.92(c).

| Applicant / Manufacturer Name and Address: | Quanta System SPA<br>Via Acquedotto, 109<br>Samarate (VA)<br>Italy 21017 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio<br>V.P. Regulatory Affairs and Quality Assurance<br>Quanta System S.p.A.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 12/11/2017 |
| Device Name: | 2940 nm Er:YAG laser handpiece |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |

Predicate Devices:

The modified device 2940nm Er:YAG handpiece is derived from the legally marketed (unmodified) device 2940nm handpiece cleared under Quanta Forte platform (K152714).

2940nm Er:YAG handpiece is substantially equivalent to the following legally marketed predicate devices:

- Primary predicate: K152714 Quanta Forte - QUANTA SYSTEM SPA Additional predicate:
- K132806 FOTONA F-22 LASER HANDPIECE, FOTONA FS-01 LASER HANDPIECE - FOTONA D.D.
- . K152153 MicroSpot Handpiece - ASCLEPION LASER TECHNOLOGIES GMBH

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## Performance Standards:

There are no mandatory performance standards for this device.

#### Description of the device:

2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece.

2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece.

lts emission is triggered by means of a footswitch connected to the console of the device it is used with.

### Intended use

2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) 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).

With microbeam end piece it is indicated for Skin resurfacing.

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Summary of technological similarities and differences of the new device in comparison with the predicate

| Specifications | Subjected device | Original<br>(unmodified<br>device) | additional predicate device | |
|---------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/<br>Device Name | 2940 nm Er:YAG<br>Laser Handpiece | Quanta Forte | Fotona F-22/FS-<br>01 Laser<br>Handpiece (F-<br>RUNNER) | MicroSpot<br>Handpiece |
| 510(K) # | - | K152714 | K132806 | K152153 |
| Submitter | Quanta System<br>S.p.A. | Quanta System<br>S.p.A. | FOTONA D.D. | Asclepion Laser<br>Technologies GmbH |
| Laser medium | Er:YAG | Er:YAG | Er:YAG | Er:YAG |
| Wavelength<br>[nm] | 2940 | 2940 | 2940 | 2940 |
| Energy, max<br>[J] | 3 | 3 | 3 | 2.5 |
| Fluence<br>[J/cm²] | Up to 95 (non<br>microbeam mode);<br>Up to 121 (with<br>stacking pulses –<br>microbeam mode) | Up to 95 (non<br>microbeam<br>mode); | Up to 300<br>(stacking pulses<br>– microbeam<br>mode) | Up to 51 (stacking<br>pulses - microbeam<br>mode with 600 µm<br>dots)<br>Up to 150<br>(stacking pulses –<br>microbeam mode<br>with 300 µm dots) |
| Pulse duration<br>[ms] | 0.3 to 1.5 ms | 1 to 1.5 ms | 0.1 to 1.5 ms | 0.1 -1.0 ms |
| Repetition rate,<br>max<br>[Hz] | 6 | 5 | 50 | 20 |
| Spot size | Ø 2, 4, 9mm<br>Ø 9mm dots array | Ø 2, 4, 9mm | 13x13 mm dots<br>array | 13x13 mm dots<br>array |

Performance data:

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The following performance data are provided in support of the substantial equivalence determination, for the Er:YAG handpiece used in conjunction with the devices it is intended to be used with.

### Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Quanta Forte device.

The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.

### Software Verification and Validation Testing

The Er:YAG handpiece does not contain any software, as it is controlled by the software of the devices it is used in conjunction with (already FDA cleared). Those software were not modified due to the use with the microbeam Er:YAG handpiece.

They successfully underwent verification and validation testing 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".

Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.

### Biocompatibility:

The biocompatibility of the Er:YAG handpiece is established based on the predicate devices.

# Conclusion:

The subject device is comparable to its primary predicate and the additional predicate devices as it has similar intended use and core fundamental technology as show in the SE table above.

Therefore, Er:YAG handpiece is substantially equivalent to its identified predicate devices.