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 Description

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:

A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
An on/off footswitch; and
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.

AI/ML Overview

The provided 510(k) summary for the LaserPeel Soft-MET Modified Erbium Laser does not include any acceptance criteria or a study demonstrating the device meets such criteria.

In fact, the document explicitly states:

Nonclinical Performance Data: None
Clinical Performance Data: None

Therefore, I cannot populate the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The 510(k) process in this instance seemingly granted substantial equivalence based on the device's technical characteristics and intended use being similar to legally marketed predicate devices, rather than requiring new performance studies with specific acceptance criteria.

Summary

{0}------------------------------------------------

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.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, Laser79-GEX 21 CFR 878.4810
Legally Marketed Predicate Devices:	Medical Laser Technologies MLT ErbiumYAGLaser System (K032599),Alma Lasers Ltd. (formerly MSq (M2) Ltd)(K042000)

Description of the LaserPeel Soft-MET Modified Erbium Laser:

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

{1}------------------------------------------------

A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
An on/off footswitch; and
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:

Nonclinical PerformanceData:	None
Clinical PerformanceData:	None
Additional Information	None requested at this time
Conclusion:	The LaserPeel Soft-MET Modified Erbium Laser issubstantially equivalent to other existing legallymarketed laser systems currently in commercialdistribution.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

{3}------------------------------------------------

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K082028

Device Name: LaserPeel Soft-MET Modified Erbium Laser

Indications for Use:

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

Page 1 of 1

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.