510(k) Report

Devices descending from K001589

1,064 later devices reach Candela Dynamic Cooling Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K180338CellulizeWard Photonics, LLC20182—
+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—
+5K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K180320dpl IIa PanelLed Technologies, Inc.201814—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+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—
+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—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+5K160821Tria SapphireTria Beauty, Inc.20160—
+5K160368EVO platformQuanta System Spa201636—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+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—
+5K141868Tria FanpTria Beauty, Inc.20140—
+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—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101415TheraclearTheravant Corporation20101—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090094Zeltiq SystemZeltiq Aesthetics200932—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081570DPL Therapy SystemLed Technologies, LLC200811
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+5K070690The Life VesselCottonwood Vessel Corporation20070—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—