K251149
- 510(k) number
- K251149
- Device name
- AviClear Laser System
- Applicant
- Cutera, Inc. CA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-07-11
- Date received
- 2025-04-14
- 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: K251149.pdf
Official FDA record: K251149
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.