GREENTON ECOLITE IPL SYSTEM

K062721 · Greenton (London) , Ltd. · GEX · Nov 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062721
• Device Name: GREENTON ECOLITE IPL SYSTEM
• Applicant: Greenton (London) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Greenton Ecolite IPL System is indicated 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 (ache vulgaris).

Device Story

Greenton Ecolite IPL System is a pulsed light, wavelength-adjustable device for dermatological applications. System features selectable handpiece aperture sizes; light emission activated via foot switch. Device weighs 110 lbs; dimensions 13.8" x 19" x 40"; powered by 110 VAC. Operated by clinicians in a professional setting. Device delivers pulsed light energy to target tissues for photocoagulation and photothermolysis. Clinical benefit includes hair reduction and treatment of vascular/pigmented lesions and acne. No software or automated analysis described.

Clinical Evidence

No clinical data provided; no nonclinical performance data provided.

Technological Characteristics

Pulsed light system with adjustable wavelength range. Features selectable handpiece aperture sizes. Energy source: 110 VAC, 15A, 50/60 Hz. Activation: foot switch. Form factor: 110 lbs, 13.8" x 19" x 40".

Indications for Use

Indicated for permanent hair reduction, treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne vulgaris.

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 System Eterna Giovinezza (K051113)

Submission Summary (Full Text)

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K062"72)

## 510(K) Summary

- Submitter: Greenton (London) Ltd. 56 Ainsdale Road London W5 1JX UNITED KINGDOM
Contact: Robert T. Handren, Jr., M.S. Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, FL 34748 352 250 8892 cell 352 314 8829 phone [phone] fax

Date Summary Prepared: July 17, 2006

Device Trade Name: Greenton Ecolite IPL System

Common Name: Pulsed Light system

Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810

- Equivalent Device: Quanta System Eterna Giovinezza (K051113)
Device Description: The Greenton Ecolite IPL System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications. Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" X 19" X 40". Electrical requirement is 110 VAC, 15A, 50/60 Hz, single phase.

Intended Use: The Greenton Ecolite IPL System is indicated 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 (ache vulgaris).

Comparison: The Greenton Ecolite IPL System is identical to the Quanta System Eterna Giovinezza, has the same indications for use, the same principle of operation, and the same wavelength range and pulse energy range as the predicate device.

Nonclinical Performance Data: None

Clinical Performance Data: None

NOV 2 1 2006

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Conclusion: The Greenton Ecolite IPL System raises no new safety or effectiveness questions in comparison to the predicate device.

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Additional Information: None

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2006

Greenton (London) Ltd % Handren Associates, Inc. Robert T. Handren, Jr., M.S. President 5818 Princess Caroline Place Leesburg, Florida 34748

Re: K062721

Trade/Device Name: Greenton Ecolite IPL 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: September 2, 2006 Received: September 12, 2006

Dear Mr. Handren:

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 - Robert T. Handren, Jr., M.S.

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.

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 yours,

Mark N. Melkerson

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

Enclosure

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## Indications for Use

510(k) Number (if known): K 062721

Device Name: Greenton Ecolite IPL System

Indications For Use:

The Greenton Ecolite IPL System is indicated 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 (ache vulgaris).

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number
1062727Page 1 of 1