SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER

K080697 · Global USA Distribution, LLC · GEX · Apr 7, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080697
• Device Name: SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
• Applicant: Global USA Distribution, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts. scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi. chloasma, verrucea, skin tags, keratoses, and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of merlanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin. 1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Device Story

Compact, self-contained Nd:YAG laser system; delivers 1064 nm and 1320 nm infrared laser energy to treatment site. Components include laser console, internal computer, control panel, optical delivery system, handset with integrated chilled sapphire cooling window, and foot switch. Operated by clinicians in dermatology settings. Computer software controls laser parameters (power output, repetition rate, energy, spot size). Clinician targets specific tissue (vascular lesions, hair follicles, soft tissue) based on wavelength; cooling window protects epidermis. Output facilitates coagulation, hemostasis, ablation, or selective photothermolysis for hair reduction. Benefits include non-invasive or minimally invasive treatment of dermatological conditions and aesthetic improvements.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Long-pulsed Nd:YAG laser; wavelengths 1064 nm and 1320 nm. Features integrated chilled sapphire optical window for epidermal cooling. System includes laser console, internal computer, control panel, and foot switch. Software-controlled operation. Class II device.

Indications for Use

Indicated for patients requiring dermatological laser treatment for vascular/pigmented lesions, benign cutaneous lesions, wrinkles, unwanted hair reduction, pseudofolliculitis barbae, or soft tissue incision/ablation. Suitable for all skin types (Fitzpatrick I-IV), including tanned skin.

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

• Sciton Profile ThermaScan (K032459)
• CoolTouch CT3S Nd: YAG Laser System (K043046)
• Cutera CoolGlide CV Laser (K023954)
• Cynosure Acclaim Dermatology Laser (K011828)
• Sciton Profile Multi-Platform System (K070388)
• Candela GentleYag (K033172)

Submission Summary (Full Text)

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K080697

APR - 7 2008

## 510(k) Summary

## AMJET Distribution, LLC SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser 510(k) Premarket Notification

| Submitter: | Global USA Distribution, LLC |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 10723 Aquila Av. S. |
| Contact Person: | Ronald E. Berglund |
| Telephone: | 952-220-3014 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | August 31, 2007 |
| Device Trade Name: | SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser |
| Classification Name: | Instrument, Powered, Laser<br>79-GEX 21 CFR 878.4810 |
| Legally Marketed Predicate<br>Devices: | Sciton Profile ThermaScan (K032459),<br>CoolTouch CT3S Nd: YAG Laser System<br>(K043046), Cutera CoolGlide CV Laser<br>(K023954), Cynosure Acclaim Dermatology<br>Laser (K011828), Sciton Profile Multi-Platform<br>System (K070388), Candela GentleYag<br>(K033172) |

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Description of the Long-Pulse Nd: Y AG Laser:

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

- 1. Laser console;
- 2. Internal computer;

3. Control panel and display;

4. Optical delivery system;

5. Hand set with integrated cooling (chilled sapphire optical window);

6. Foot switch

The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

Intended Use of the Long-Pulse Nd: Y AG Laser:

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts. scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi. chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of merlanin in hair follicles, and for the treatment of pseudofolliculitis

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| | barbae. Indicated for use on all skin types<br>(Fitzpatrick I-IV), including tanned skin. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1320 nm: For use in dermatology for incision,<br>excision, ablation and vaporization with hemostasis<br>of soft tissue. For use in the treatment of fine lines<br>and wrinkles. It is also indicated for the treatment of<br>back acne and atrophic acne scars. |
| Nonclinical Performance<br>Data: | None |
| Clinical Performance<br>Data: | None |
| Additional Information | None requested at this time |
| Conclusion: | The SKIN CLEAR SRVH Long Pulsed Nd:YAG<br>Laser shares the same indications for use, similar<br>design features (including wavelengths, laser<br>medium, power supply, cooling and control<br>systems), functional features (including power<br>output, repetition rate, energy, spot sizes and energy<br>fluence), and is therefore substantially equivalent to<br>the above legally marketed laser systems currently<br>in commercial distribution. |

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image. The text is in all capital letters.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2008

Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine Sr. Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

Re: K080697

Trade/Device Name: SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser 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: March 31, 2008 Received: April 1, 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 N. Mullison

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): _ KO80697

Device Name: SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser

Indications for Use:

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

| Prescription Use: X AND/OR Over-The-Counter Use |
|----------------------------------------------------|
| (Part 21 CFR 801 Subpart D) (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)

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

510(k) Number_KO80697