K251435
- 510(k) number
- K251435
- Device name
- InbellaIgnite RF System
- Applicant
- Inbella Medical, Inc. CA
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-01-27
- Date received
- 2025-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251435.pdf
Official FDA record: K251435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.