510(k) Report

Devices descending from K001589

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K210084SilkroHironic Co., Ltd.20223—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K202041Opera EvoQuanta System Spa20200—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K192430Epic 980Biolase, Inc.20195—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K111689StlaseDental Photonics, Inc.201222—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+10K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212331BodySculpRohrer Aesthetics, LLC20211—
+10K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K192970SlimusHironic Co., Ltd.20200—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202503ChromeQuanta System Spa202012—
+10K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K193486Epic 980Biolase, Inc.20202—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K171992SculpSureCynosure, Inc.20178—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—