K231901
- 510(k) number
- K231901
- Device name
- Hakon, Hakon Smart
- Applicant
- Medical San Indústria DE Equipamentos Médicos Ltda. BR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2023-09-28
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231901.pdf
Official FDA record: K231901
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.