510(k) Report

Devices descending from K150035

31 later devices reach V10 system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+1K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+1K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+1K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+1K170637sensiFirmEl Global Trade, Ltd.20173—
+1K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+1K161043Profound SystemSyneron Candela Corporation20160—
+1K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+1K153568InMode Plus SystemInmode MD, Ltd.201618—
+1K152611V20 systemViora, Ltd.20164—
+2K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+2K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+2K191855EmFace DeviceInmode MD, Ltd.20191—
+2K181095RF-ReliefEl Global Trade, Ltd.20181—
+2K172302InMode PLUS SystemInmode MD, Ltd.201713—
+3K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+3K250734OptiLUV DevicePollogen, Ltd.20250—
+3K243139Reverso Pro SystemIndiba S. A. U.20250—
+3K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K183450EmBody SystemInmode MD, Ltd.20198—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+4K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+4K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+5K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+5K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K230167BACK 4Swims America Corp20230—
+5K230037BACK 3Swims America Corp20230—