# K252515: Q-Switched Nd:Yag laser (K690)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Keylaser Sci-Tech Co.,Ltd
- Decided: Nov 6, 2025 after 87 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: 15 generations back to K910422 (1992). 131 ancestors in all.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202758: Nd: YAG Laser Therapy Systems HM-YL900, Shangdong Huamei Technology Co., Ltd. (2020) Summary page 6.

## Indications for use
The Q-Switch Nd:Yag laser is intended for use in removal of dark ink (black, blue and brown) tattoo, removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, removal or lightening of unwanted hair with or without adjuvant preparation, skin resurfacing procedures for the treatment of acne scars and wrinkles.

Source page: https://510kreport.com/device/K252515
Methodology: https://510kreport.com/methodology