K252519
- 510(k) number
- K252519
- Device name
- CO2 Laser Therapy System (K106)
- Applicant
- Hebei Keylaser Sci-Tech Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-07
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K252519.pdf
Official FDA record: K252519
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.