510(k) Report

Devices descending from K133837

33 later devices reach Viora V-Total through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+1K142093V20 SystemViora, Ltd.201432—
+2K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+2K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+2K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+2K152611V20 systemViora, Ltd.20164—
+2K150035V10 systemViora, Ltd.201531—
+3K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+3K170637sensiFirmEl Global Trade, Ltd.20173—
+3K161043Profound SystemSyneron Candela Corporation20160—
+3K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+3K153568InMode Plus SystemInmode MD, Ltd.201618—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+4K191855EmFace DeviceInmode MD, Ltd.20191—
+4K181095RF-ReliefEl Global Trade, Ltd.20181—
+4K172302InMode PLUS SystemInmode MD, Ltd.201713—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K250734OptiLUV DevicePollogen, Ltd.20250—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K183450EmBody SystemInmode MD, Ltd.20198—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+6K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+7K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K230167BACK 4Swims America Corp20230—
+7K230037BACK 3Swims America Corp20230—