K243037
- 510(k) number
- K243037
- Device name
- Diode Laser System model Dawn-S
- Applicant
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-12-26
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243037.pdf
Official FDA record: K243037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.