510(k) Report

Devices descending from K082876

57 later devices reach Beamax/ Formax Pulsed Light Device Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+2K192856MT OneM&T S.R.L.20202—
+2K180508Joule SystemSciton, Inc20183—
+2K172413MT ONEM&T S.R.L.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K152714Quanta ForteQuanta System Spa201513—
+2K133837Viora V-TotalViora, Ltd.201433—
+3K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K210847UltraClear Fractional Laser SystemFa International, LP20210—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191942MT One DiamondM&T S.R.L.20191—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+3K142093V20 SystemViora, Ltd.201432—
+4K234057NirvanaEl.En S.P.A.20240—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200736Stardust MedI.T.S. Group S.R.L.20200—
+4K200616E>EyeCE-Swin20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K230167BACK 4Swims America Corp20230—
+9K230037BACK 3Swims America Corp20230—