K233803
- 510(k) number
- K233803
- Device name
- UltraClear Laser System (N/A)
- Applicant
- Acclaro Corporation RI · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-08
- Date received
- 2023-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233803.pdf
Official FDA record: K233803
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.