510(k) Report

Devices descending from K200947

15 later devices reach InMode System with the Morhpeus8 Applicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+1K240999Legend X Applicator VOPollogen, Ltd.20241—
+1K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+1K221571InMode Multi-systemInMode, Ltd.20222—
+2K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+2K253803MILAN SystemLumenis Be, Ltd.20260—
+2K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+2K251254Ignite RF SystemInMode, Ltd.20260—
+2K252367InbellaMulti SystemInbella Medical, Inc.20250—
+2K251632Optimas MAX SystemInMode, Ltd.20251—
+2K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+2K233642InMode RF SystemInMode, Ltd.20244—
+3K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+3K240780InMode RF SystemInMode, Ltd.20243—
+4K243737Inbella RF SystemInbella Medical, Inc.20250—