510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243488Vmat ProTermosalud20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K23299210THERMATentech, Inc.20230—
+7K233237xeo+ FamilyCutera, Inc.20230—
+7K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+7K232236EchoQuanta System Spa20230—
+7K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+7K232274IPL hair removal deviceLumenessa Corp20230—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+7K230663DensityJeisys Medical, Inc.20232—
+7K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+7K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+7K223680Eneka ProTermosalud20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+7K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+7K221989The OligioWontech Co., Ltd.20222—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+7K221761SoleaConvergent Dental, Inc.202201
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K213261EpilMENeauvia North America20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+7K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+7K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+7K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+7K213428EdgeProBiolase, Inc.20210—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+7K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—