# K083272: Skinclear Q-Switched ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Global USA Distribution, LLC
- Decided: Dec 16, 2008 after 40 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: 4 generations back to K950019 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041011: Ultralight II ND:Yag Laser System, Sandstone Medical Technologies, LLC (2004) Summary page 1.

## 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: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)

Source page: https://510kreport.com/device/K083272
Methodology: https://510kreport.com/methodology