K231495
- 510(k) number
- K231495
- Device name
- The Evolve System with the Transform Applicator
- Applicant
- InMode , Ltd. IL
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-10-13
- Date received
- 2023-05-23
- 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: K231495.pdf
Official FDA record: K231495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.