QUANTA SYSTEM ETRNA GIOVINEZZA

K051113 · Quanta System Spa · GEX · Jan 4, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K051113
• Device Name: QUANTA SYSTEM ETRNA GIOVINEZZA
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quanta System Eterna Giovinezza system is intended for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (acne vulgaris)

Device Story

Pulsed light system for dermatological applications; utilizes adjustable wavelength range and selectable handpiece aperture sizes. Operated by physician via foot switch activation. Device delivers light energy to target tissues for photothermolysis and photocoagulation. Used in clinical settings for hair reduction, vascular lesion treatment, and acne management. System dimensions 13.8" x 19" x 40"; weight 110 lbs; powered by 110 VAC. Provides non-invasive treatment options for various skin conditions.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Pulsed light system; adjustable wavelength range; selectable handpiece aperture sizes; foot switch activation; 110 VAC, 15A, 50 Hz power requirement; dimensions 13.8" x 19" x 40"; weight 110 lbs.

Indications for Use

Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of facial and leg veins, treatment of benign pigmented lesions, inflammatory acne (acne vulgaris), and cutaneous lesions including warts, scars, and striae.

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

• Palomar Medical Products, Inc.
• Cynosure, Inc.

Submission Summary (Full Text)

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## 510(K) Summary

| Submitter: | Quanta System SpA<br>Via IV Novembre, 116<br>21058 Solbiate Olona<br>VA / Italy |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Isabella Carrer<br>Medical Division Manager |
| Date Summary Prepared: | April 29, 2005 |
| Device Trade Name: | Quanta System Eterna Giovinezza system |
| Common Name: | Pulsed Light system |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | Palomar Medical Products, Inc. and Cynosure, Inc. |
| Device Description: | The Quanta System Eterna Giovinezza system is a pulsed light,<br>wavelength range adjustable system. It provides selectable handpiece<br>aperture sizes for a variety of applications<br>Light emission activation is by foot switch. Overall weight of the<br>system is 110 lbs., and the size is 13.8" x 19" x 40" (LxWxH).<br>Electrical requirement is 110 VAC, 15A, 50 Hz, single phase. |
| Intended Use: | The Quanta System Eterna Giovinezza is intended for permanent hair<br>reduction, photocoagulation of dermatological vascular lesions,<br>photothermolysis of blood vessels (treatment of facial and leg veins),<br>and treatment of benign pigmented lesions and inflammatory acne<br>(acne vulgaris) |
| Comparison: | The Quanta System Eterna Giovinezza system has similar indications<br>for use, the same principle of operation, and essentially the same<br>wavelength range and pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Quanta System Eterna Giovinezza system is a safe and effective<br>device for the indicated uses. |
| Additional Information: | none |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces left and has a curved beak. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 4 2006

Ouanta System, SpA. % George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824-4145

Re: K051113

Trade/Device Name: Quanta System Eterna Giovinezza 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 Dated: December 2, 2005 Received: December 5, 2005

Dear Mr. Cho:

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

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Page 2 - Mr. Cho

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chabane Bnehm

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

Enclosure

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KO SILIS 5 l (k) Number (if known): __________________________________________________________________________________________________________________________________________________

Device Name: _ Quanta System Eterna Giovinezza systems; Standard, Plus and Compact

Indications For Use:

The Quanta System Eterna Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, ¡¡hotothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.

> Prescriptive Use OR >> (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - C ONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cainbare Budum
(Division Signa

Division of General, Restorative, and Neurological Devices

510(k) Numbe