510(k) Report

Devices descending from K063249

58 later devices reach Beamax through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K192856MT OneM&T S.R.L.20202—
+3K180508Joule SystemSciton, Inc20183—
+3K172413MT ONEM&T S.R.L.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K152714Quanta ForteQuanta System Spa201513—
+3K133837Viora V-TotalViora, Ltd.201433—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K142093V20 SystemViora, Ltd.201432—
+5K234057NirvanaEl.En S.P.A.20240—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200616E>EyeCE-Swin20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K152611V20 systemViora, Ltd.20164—
+5K150035V10 systemViora, Ltd.201531—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—