FDA applicant
Inmode MD, Ltd.
FDA records 21 decisions for Inmode MD, Ltd. (Yokneam, IL) from 2013 to 2021: 21 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Inmode MD, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Inmode MD, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Inmode”
FDA records each applicant name separately; these may or may not be the same firm.