SKINCLEAR Q-SWITCHED ND:YAG LASER

K083272 · Global USA Distribution, LLC · GEX · Dec 16, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K083272
• Device Name: SKINCLEAR Q-SWITCHED ND:YAG LASER
• Applicant: Global USA Distribution, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SkinClear Q-Switched Nd:YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal of pigmented lesions, and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV). The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV).

Device Story

Q-switched Nd:YAG laser system; console-based with power supply, electronic circuit board, cooling system, LCD, handpiece, and footswitch. Emits 1064 nm and 532 nm wavelengths. Used by clinicians for tattoo removal, hair removal, and treatment of vascular/pigmented lesions. Device delivers laser energy to target tissues; operator controls parameters via console interface. Clinical benefit includes removal or lightening of tattoos, hair, and lesions. No software-based automated analysis described.

Clinical Evidence

No clinical data.

Technological Characteristics

Q-switched Nd:YAG laser; 1064 nm and 532 nm wavelengths. System includes console, power supply, cooling system, LCD, and handpiece. No specific material standards or software algorithm class provided.

Indications for Use

Indicated for dark ink tattoo removal, pigmented lesion removal, and hair removal/lightening (1064 nm); red ink tattoo removal and vascular/pigmented lesion treatment (532 nm). For all skin types (Fitzpatrick I-IV).

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

• UltraLight II Nd: YAG Laser System (K041011)

Submission Summary (Full Text)

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K083272

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DEC 1 6 2008

# 510(k) Summary

## Global USA Distribution, LLC SkinClear O-Switched Nd: YAG Laser

| Submitter: | Global USA Distribution, LLC |
|-------------------------------------------------------------------------|----------------------------------------------|
| Address: | 10723 Aquila Av. S.<br>Minneapolis, MN 55438 |
| Contact Person: | Matt Makousky |
| Telephone: | 952-703-5373 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | July 1, 2008 |
| Device Trade Name: | SkinClear Q-Switched Nd:YAG Laser |
| Classification Name: | Instrument, Powered, Laser |
| Legally Marketed Predicate Devices: Sandstone Medical Technologies, LLC | |

UltraLight II Nd: YAG Laser System (K041011)

## Description of the SkinClear Q-Switched Nd: YAG Laser:

The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.

#### Intended Use of the : SkinClear Q-Switched Nd:YAG Laser:

The SkinClear Q-Switched Nd:YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal of pigmented lesions, and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV).

The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV).

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#### Summary of technological characteristics:

The SkinClear Q-Switched Nd: Y AG Laser and the Sandstone Medical Technologies, LLC UltraLight II Nd: YAG Laser System share the same wavelengths, energy output, pulse duration, and pulse repetition rate.

#### Nonclinical Performance Data:

None

Clinical Performance Data:

None

Additional Information:

None requested at this time

Conclusion:

The SkinClear Q-Switched Nd:YAG Laser is substantially equivalent to other existing legally marketed laser systems currently in commercial distribution.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global USA Distribution, LLC % Underwriters Laboratory, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062

Re: K083272

Trade/Device Name: SkinClear™ Q-Switched Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

DEC 1 6 2008

Regulatory Class: II Product Code: GEX Dated: December 3, 2008 Received: December 4, 2008

Dear Mr. Devine:

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. Ned Devine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M. Millman

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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K08327

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# Indications for Use

510(k) Number (if known):

Device Name: SkinClear™ Q-Switched Nd: Y AG Laser System

Indications for Use:

The SkinClear Q-Switched Nd: YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions. and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)

The SkinClear Q-Switched Nd: Y AG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)

Prescription Use: X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Mest R.P. Dyke for rx

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

**510(k) Number** K083272