K252215
- 510(k) number
- K252215
- Device name
- InbellaMAX System
- Applicant
- Inbella Medical , Ltd. CA
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-07-25
- Date received
- 2025-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252215.pdf
Official FDA record: K252215
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.