510(k) Report

Devices descending from K030426

563 later devices reach Omnilux Red through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+7K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+7K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+7K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+7K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+7K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+7K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+7K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+7K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+7K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K193426Elite iQCynosure, LLC20201—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160368EVO platformQuanta System Spa201636—
+7K152012EVO platformQuanta System Spa201537—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—