K250065
- 510(k) number
- K250065
- Device name
- DENSITY; DENZA; DENSITY Noir
- Applicant
- Jeisys Medical Incorporated KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-07-08
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250065.pdf
Official FDA record: K250065
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.