# K041011: Ultralight II ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Dec 14, 2004 after 238 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: 3 generations back to K950019 (1995). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003460: Palomar Clear Light ND: Yag Laser System, Palomar Medical Technologies, Inc. (2001) Summary page 1.
- K970808: Medlite IV Q-Switched, Frequency Doubled, ND:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 1.
- K983054: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser, Continuum Biomedical, Inc. (1999) Summary page 1.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001) Summary page 1.

## Most influential descendants
- K082407: Modification to Ultralight II ND: Yag Laser System (2009), 3 descendants of its own
- 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
- K083272: Skinclear Q-Switched ND:Yag Laser (2008), 0 descendants of its own

## Indications for use
At the 1064 nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. At the 532 nm 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. lentigines, ephildes)

Source page: https://510kreport.com/device/K041011
Methodology: https://510kreport.com/methodology