LASERPEEL SOFT-MET MODIFIED ERBIUM LASER

K082028 · Global USA Distribution, LLC · GEX · Aug 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082028
• Device Name: LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
• Applicant: Global USA Distribution, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.

Device Story

LaserPeel Soft-MET Modified Erbium Laser is a compact, self-contained surgical laser system. It delivers 2940 nm infrared laser energy to soft tissue for coagulation, vaporization, ablation, or cutting. System components include a console (power supply, electronics, cooling, LCD), handpiece (laser cavity, optical delivery), footswitch, and trolley. Operated by clinicians in dermatology, plastic surgery, oral surgery, and ophthalmology settings. Software controls device operation. Energy delivery enables precise tissue modification for skin resurfacing, wrinkle reduction, and lesion removal, providing therapeutic benefits through controlled tissue ablation.

Clinical Evidence

No clinical data provided. No nonclinical performance data provided.

Technological Characteristics

Erbium laser system; 2940 nm wavelength; compact console with LCD, handpiece with laser cavity, footswitch, and trolley. Software-controlled operation. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for Fitzpatrick skin types I-V requiring coagulation, vaporization, ablation, or cutting of soft tissue in dermatology, plastic surgery, oral surgery, and ophthalmology. Specific applications include skin resurfacing, wrinkle treatment, and superficial skin lesions.

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

• Medical Laser Technologies MLT ErbiumYAG Laser System (K032599)
• Alma Lasers Ltd. (formerly MSq (M2) Ltd) (K042000)

Submission Summary (Full Text)

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## 510(k) Summary

### Global USA Distribution, LLC LaserPeel Soft-MET Modified Erbium Laser 510(k) Premarket Notification

AUG - 8 2008

| 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: | April 1, 2008 |
| Device Trade Name: | LaserPeel Soft-MET Modified Erbium Laser |
| Classification Name: | Instrument, Powered, Laser<br>79-GEX 21 CFR 878.4810 |
| Legally Marketed Predicate Devices: | Medical Laser Technologies MLT ErbiumYAG<br>Laser System (K032599),<br>Alma Lasers Ltd. (formerly MSq (M2) Ltd)<br>(K042000) |

#### Description of the LaserPeel Soft-MET Modified Erbium Laser:

The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:

> 1. A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);

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2. A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:

3. An on/off footswitch; and

4. An integrated trolley/cart.

The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.

#### Intended Use of the LaserPeel Soft-MET Modified Erbium Laser:

Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.

| Nonclinical Performance<br>Data: | None |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance<br>Data: | None |
| Additional Information | None requested at this time |
| Conclusion: | The LaserPeel Soft-MET Modified Erbium Laser is<br>substantially equivalent to other existing legally<br>marketed laser systems currently in commercial<br>distribution. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096

AUG - 8 2008

Re: K082028

Trade/Device Name: LaserPeel Soft-MET Modified Erbium 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: July 31, 2008 Received: August 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 H. Mulhausen

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): K082028

Device Name: LaserPeel Soft-MET Modified Erbium Laser

Indications for Use:

Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.

Prescription Use: X (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)

Sign-Off) (Division Division of General, Restorative, and Neurological 510(%) Number

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