K253123
- 510(k) number
- K253123
- Device name
- CuRAS hybrid
- Applicant
- Classys, Inc. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-20
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253123.pdf
Official FDA record: K253123
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.