# K130250: Qyag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: May 3, 2013 after 91 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: 16 generations back to K943450 (1995). 282 ancestors in all.
No later device cites it as a predicate yet.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061436: Palomar Q-Yag 5 ND:Yag Laser System, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K083899: Revlite Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2009) Summary page 2.
- K123168: Q-Plus T+ Ipl Laser System, Quanta System Spa (2012) Summary page 2.
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 2.

## Indications for use
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark (i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus, Nevus-of-Ota and Caf6-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.

Source page: https://510kreport.com/device/K130250
Methodology: https://510kreport.com/methodology