K240386
- 510(k) number
- K240386
- Device name
- Picosecond Nd:YAG Laser Systems (BL-C10)
- Applicant
- Shanghai Bele Medical Technology Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-16
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240386.pdf
Official FDA record: K240386
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.