The InMode System with the Morpheus8 Applicators

K231790 is the FDA 510(k) clearance record for The InMode System with the Morpheus8 Applicators, a class II device, cleared for InMode , Ltd. on 2023-07-20 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 15 510(k) clearances for InMode , Ltd., from 2019-12-17 to 2026-01-15. As of 2026-09-10, FDA records show no recalls naming K231790.