K242598
- 510(k) number
- K242598
- Device name
- DEFINE System (AG612444A)
- Applicant
- InMode , Ltd. IL
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2024-11-14
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242598.pdf
Official FDA record: K242598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.