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
+9K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+9K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+9K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K221761SoleaConvergent Dental, Inc.202201
+9K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K213428EdgeProBiolase, Inc.20210—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203299CellFX SystemPulse Biosciences, Inc.20214—
+9K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K180359BTL-FR2000BTL Industries, Inc.20189—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K182669Youlaser CO2Quanta System Spa20181—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K160312Fraxis DuoIlooda Co,., Ltd.201614—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K160075Accent XLAlma Lasers, Inc.20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+9K150664NeoLasSheaumann Laser, Inc.20151—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+9K150027CYMAWhitecap Technologies, LLC20150—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K130501IntensifEndymed Medical, Ltd.201457—
+9K131758Surgen UPollogen, Ltd.20135—
+9K132754Neogen PSR SystemEnergist, Ltd.20132—
+9K131839DC 7Dc International, LLC20130—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K120513Glow by EndymedEndymed Medical, Ltd.20125—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K110375Blueshine's Gold SeriesBlueshine Srl20124—
+9K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+9K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+9K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+9K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+9K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+9K082938EzlaseBiolase Technology, Inc.200850—
+9K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+9K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+9K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+9K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+10K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+10K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+10K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+10K253123CuRAS hybridClassys, Inc.20250—