K254271
- 510(k) number
- K254271
- Device name
- CAPRI
- Applicant
- ORO Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-02-26
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K254271.pdf
Official FDA record: K254271
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.