510(k) Report

Devices descending from K102461

24 later devices reach Fractora through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221571InMode Multi-systemInMode, Ltd.20222—
+1K203299CellFX SystemPulse Biosciences, Inc.20214—
+1K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+1K131758Surgen UPollogen, Ltd.20135—
+2K251632Optimas MAX SystemInMode, Ltd.20251—
+2K211444CellFX SystemPulse Biosciences, Inc.20213—
+2K202988Tixel SystemNovoxel, Ltd.20211—
+2K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+2K191065Venus VivaTMVenus Concept USA, Inc.20200—
+2K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+2K153717Venus Versa SystemVenus Concept, Ltd.20161—
+3K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+3K243139Reverso Pro SystemIndiba S. A. U.20250—
+3K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+3K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+3K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+3K213674CellFX SystemPulse Biosciences, Inc.20220—
+3K222075CellFX SystemPulse Biosciences, Inc.20220—
+3K221671CellFX® SystemPulse Biosciences, Inc.20220—
+3K212107ReversoIntelis Instruments, Ltd.20211—
+3K173503Pollogen Legend SystemPollogen, Ltd.20183—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+5K250281Deka LotusEl.En S.P.A.20250—