510(k) Report

Devices descending from K192695

16 later devices reach InMode System with the Morpheus8 (Fractora) Applicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+2K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+2K240999Legend X Applicator VOPollogen, Ltd.20241—
+2K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+2K221571InMode Multi-systemInMode, Ltd.20222—
+3K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+3K253803MILAN SystemLumenis Be, Ltd.20260—
+3K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+3K251254Ignite RF SystemInMode, Ltd.20260—
+3K252367InbellaMulti SystemInbella Medical, Inc.20250—
+3K251632Optimas MAX SystemInMode, Ltd.20251—
+3K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+3K233642InMode RF SystemInMode, Ltd.20244—
+4K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+4K240780InMode RF SystemInMode, Ltd.20243—
+5K243737Inbella RF SystemInbella Medical, Inc.20250—