K251327
- 510(k) number
- K251327
- Device name
- XERF
- Applicant
- Lutronic Corporation KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-08-11
- Date received
- 2025-04-30
- 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: K251327.pdf
Official FDA record: K251327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.