K242941
- 510(k) number
- K242941
- Device name
- CO2 Laser Therapy Systems (SHE-LSP003-1)
- Applicant
- Beijing Sano Laser S&T Development Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-01-27
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242941.pdf
Official FDA record: K242941
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.