K252515
- 510(k) number
- K252515
- Device name
- Q-Switched Nd:Yag laser (K690)
- Applicant
- Hebei Keylaser Sci-Tech Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-06
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K252515.pdf
Official FDA record: K252515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.