510(k) Report

Devices descending from K013623

856 later devices reach Clearlight Phototheraphy System, Model CL 420 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070690The Life VesselCottonwood Vessel Corporation20070—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221083Smartlux MiniMedmix Co., Ltd.20222—
+4K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+4K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+4K200616E>EyeCE-Swin20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+4K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+4K180508Joule SystemSciton, Inc20183—
+4K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+4K180320dpl IIa PanelLed Technologies, Inc.201814—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+4K172413MT ONEM&T S.R.L.20175—
+4K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+4K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC20160—
+4K160691Acne Light Therapy WandZuko, Inc.201650—
+4K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+4K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150370Nutra Light AdvancedNutra Luxe MD, LLC20150—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+4K140471Pro X Otc 5La Lumiere, LLC2015107—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—