K260974
- 510(k) number
- K260974
- Device name
- CO2 Laser Machine (Monica-I,Monica-II)
- Applicant
- Nanjing Bestview Laser S&T Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-07
- Date received
- 2026-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K260974.pdf
Official FDA record: K260974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.