# K082407: Modification to Ultralight II ND: Yag Laser System

- Pathway: 510(k) (Special)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Feb 3, 2009 after 166 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.
3 later devices descend from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K110502: Triplex ER. Yag / ND: Yag System (2011), 2 descendants of its own
- K123777: Multilaser System (2013), 1 descendant of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
At the 1064 unm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. At the 532 unm wavelength - removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ep~hildes)

Source page: https://510kreport.com/device/K082407
Methodology: https://510kreport.com/methodology