# K082028: Laserpeel Soft-Met Modified Erbium Laser

- Pathway: 510(k) (Traditional)
- Applicant: Global USA Distribution, LLC
- Decided: Aug 8, 2008 after 22 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910422 (1992). 159 ancestors in all.
No later device cites it as a predicate yet.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System, Medical Laser Technologies, LLC (2003) Summary page 1.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K082028
Methodology: https://510kreport.com/methodology