# K110502: Triplex ER. Yag / ND: Yag System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Apr 27, 2011 after 64 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: 5 generations back to K954013 (1996). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 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.
- K082407: Modification to Ultralight II ND: Yag Laser System, Sandstone Medical Technologies, LLC (2009) Summary page 1.

## Most influential descendants
- K123777: Multilaser System (2013), 1 descendant of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: * At the 1064nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. * At the 532nm 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 (eg: lentigies, ephildes)

Source page: https://510kreport.com/device/K110502
Methodology: https://510kreport.com/methodology