510(k) Report

Devices descending from K180189

38 later devices reach InMode System with Fractora3D/3D-90 Applicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+1K221571InMode Multi-systemInMode, Ltd.20222—
+1K192545PotenzaJeisys Medical Incorporated202020—
+1K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+2K251632Optimas MAX SystemInMode, Ltd.20251—
+2K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+2K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+2K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+2K203728DarwinLuvo Medical Technologies, Inc.20211—
+2K201685PotenzaJeisys Medical, Inc.20219—
+2K201735PlaDuo SystemShenB Co., Ltd.20203—
+2K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+3K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+3K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+3K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K231216PotenzaJeisys Medical, Inc.20244—
+3K231287PotenzaJeisys Medical, Inc.20241—
+3K240999Legend X Applicator VOPollogen, Ltd.20241—
+3K230837PlazMagikAgnes Medical Co., Ltd.20240—
+3K232223PlaDuo SystemShenB Co., Ltd.20230—
+3K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+3K212472AgeJetTriworks Group Srl20220—
+3K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K254185Potenza PrimeJeisys Medical Incorporated20260—
+4K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+4K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+4K253803MILAN SystemLumenis Be, Ltd.20260—
+4K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+4K251254Ignite RF SystemInMode, Ltd.20260—
+4K252367InbellaMulti SystemInbella Medical, Inc.20250—
+4K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+4K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+4K233642InMode RF SystemInMode, Ltd.20244—
+5K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+5K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+5K240780InMode RF SystemInMode, Ltd.20243—
+6K243737Inbella RF SystemInbella Medical, Inc.20250—