# K131857: Q-Switched ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Honkon Technologies Co., Ltd.
- Decided: Jan 16, 2014 after 206 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 K014234 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063834: Revlite C6 Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2007) Summary page 2.

## Indications for use
1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue) Ota's nevus 532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos

Source page: https://510kreport.com/device/K131857
Methodology: https://510kreport.com/methodology