510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K233237xeo+ FamilyCutera, Inc.20230—
+6K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+6K232274IPL hair removal deviceLumenessa Corp20230—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K230077LaserMENeauvia North America20232—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+6K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+6K223680Eneka ProTermosalud20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+6K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K213261EpilMENeauvia North America20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+6K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+6K213594Echolaser X4Elesta S.P.A20221—
+6K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K193201BTL-785FBtl20208—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193426Elite iQCynosure, LLC20201—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd.201966—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K183217IPL Hair Removal DeviceTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K180338CellulizeWard Photonics, LLC20182—
+6K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd.201836—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K181659Avologi ENEOPremier North America, Inc.20184—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—