K250936
- 510(k) number
- K250936
- Device name
- Q-Switched Nd:YAG Laser (SHE-LSP101-1)
- Applicant
- Beijing Sano Laser S&T Development Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-06-12
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250936.pdf
Official FDA record: K250936
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.