K250261
- 510(k) number
- K250261
- Device name
- Heager Medical Laser Family (Sabrina/Adolf)
- Applicant
- Heager GmbH DE
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-08-26
- Date received
- 2025-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250261.pdf
Official FDA record: K250261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.