K251632
- 510(k) number
- K251632
- Device name
- Optimas MAX System
- Applicant
- InMode , Ltd. FR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-06-26
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251632.pdf
Official FDA record: K251632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.