510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K243139Reverso Pro SystemIndiba S. A. U.20250—
+11K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+11K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+11K213674CellFX SystemPulse Biosciences, Inc.20220—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K222075CellFX SystemPulse Biosciences, Inc.20220—
+11K221671CellFX® SystemPulse Biosciences, Inc.20220—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K210084SilkroHironic Co., Ltd.20223—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K211639BTL-785WBTL Industries, Inc.20227—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K212107ReversoIntelis Instruments, Ltd.20211—
+11K202503ChromeQuanta System Spa202012—
+11K202041Opera EvoQuanta System Spa20200—
+11K192545PotenzaJeisys Medical Incorporated202020—
+11K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+11K192430Epic 980Biolase, Inc.20195—
+11K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+11K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+11K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K183450EmBody SystemInmode MD, Ltd.20198—
+11K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+11K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+11K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+11K173503Pollogen Legend SystemPollogen, Ltd.20183—
+11K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+11K171111SculpsureCynosure, Inc.201710—
+11K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+11K170500SIROLaser Advance+Dentsply Sirona201721—
+11K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+11K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+11K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+11K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+11K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+11K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+11K111689StlaseDental Photonics, Inc.201222—
+12K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+12K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+12K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+12K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+12K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+12K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+12K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+12K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+12K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K233123SilkroHironic Co., Ltd.20241—
+12K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+12K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+12K232106Air Gap FiberWontech Co., Ltd.20240—
+12K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+12K233147PiXel8-RFRohrer Aesthetics20230—
+12K222556BTL-785XBTL Industries, Inc.20235—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K211000AcutronIlooda Co,., Ltd.20220—
+12K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+12K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+12K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+12K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+12K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K201685PotenzaJeisys Medical, Inc.20219—
+12K201735PlaDuo SystemShenB Co., Ltd.20203—