K251230
- 510(k) number
- K251230
- Device name
- The Alma Hybrid Laser System
- Applicant
- Alma Lasers, Inc. IL · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-05-21
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251230.pdf
Official FDA record: K251230
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.