# K061436: Palomar Q-Yag 5 ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Dec 6, 2006 after 196 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
No predicates in its family tree.
120 later devices descend from it; 5 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Continuum Electro-Optics, Inc. Medlite C3 Q-Switched Nd:YAG Laser: named in the summary without a submission number
- (no number) Palomar Q-YAG 5 Nd:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K113588: Spectra Laser System (2012), 82 descendants of its own
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), 57 descendants of its own
- K143105: Picosure Workstation (2015), 49 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K110370: Q-Clear (2011), 35 descendants of its own

## Indications for use
The Palomar Q-YAG 5TM Nd:YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g., black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and caf6-au-lait, and the removal or lightening of hair. The 532 nm wavelength is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides). The 1064/532 nm blended wavelength is indicated for tattoo removal.

Source page: https://510kreport.com/device/K061436
Methodology: https://510kreport.com/methodology