K241670
- 510(k) number
- K241670
- Device name
- Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
- Applicant
- Beijing Adss Development Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-12-20
- Date received
- 2024-06-11
- 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: K241670.pdf
Official FDA record: K241670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.