510(k) Report

Devices descending from K924647

1,499 later devices reach DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K242241SunnyShenB Co., Ltd.20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K243488Vmat ProTermosalud20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K240311JETT Medical IICompex, Spol, S.R.O.20250—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+9K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+9K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241656Eneka SelectifTermosalud20241—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+9K240248Volnewmer™Classys, Inc.20241—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+9K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+9K23299210THERMATentech, Inc.20230—
+9K233237xeo+ FamilyCutera, Inc.20230—
+9K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+9K232236EchoQuanta System Spa20230—
+9K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+9K232274IPL hair removal deviceLumenessa Corp20230—
+9K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+9K231146AliTightAlic Iotech, LLC20230—
+9K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+9K230663DensityJeisys Medical, Inc.20232—
+9K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230077LaserMENeauvia North America20232—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+9K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+9K223680Eneka ProTermosalud20230—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+9K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+9K221989The OligioWontech Co., Ltd.20222—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+9K221761SoleaConvergent Dental, Inc.202201
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+9K213261EpilMENeauvia North America20220—
+9K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+9K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+9K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+9K213594Echolaser X4Elesta S.P.A20221—
+9K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+9K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+9K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+9K213428EdgeProBiolase, Inc.20210—
+9K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+9K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+9K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+9K202955Contour Light CL-100Contour Research, LLC20218—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+9K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K193266MIINMedico USA, Inc.20210—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+9K192275invisa-RED ELITEIR Technology, LLC20201—
+9K201406PicowonWontech Co., Ltd.20200—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+9K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—