510(k) Report

Devices descending from K960772

1,286 later devices reach Photoderm PL. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193201BTL-785FBtl20208—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+5K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K180338CellulizeWard Photonics, LLC20182—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K181659Avologi ENEOPremier North America, Inc.20184—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K180320dpl IIa PanelLed Technologies, Inc.201814—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172111Vevazz LEDVevazz, LLC20170—
+5K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+5K171702Exciplex308nmClarteis20175—
+5K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+5K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+5K162784Silk'n HSTHome Skinovations, Ltd.20171—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K160821Tria SapphireTria Beauty, Inc.20160—
+5K160368EVO platformQuanta System Spa201636—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+5K133364Picosure WorkstationCynosure, Inc.201451—