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
+8K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+8K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+8K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+8K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+8K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K223147myLEDmaskMyblend20234—
+8K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+8K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+8K221083Smartlux MiniMedmix Co., Ltd.20222—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+8K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K193266MIINMedico USA, Inc.20210—
+8K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K191086ExciplexClarteis20194—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+8K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+8K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+8K183247dpl FacewareLed Technologies, Inc.201910—
+8K182173Joule SystemSciton, Inc20195—
+8K183118dpl SpotLiteLed Technologies, Inc.201922—
+8K180875Poly RejuvMedtek Skincare, LLC20180—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+8K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+8K1718212 Face / Face EvolutionHeat IN A Click201858—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171648BM.IrisBluecore Co., Ltd.20172—
+8K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K170068Softcure 96Wellray Medical Laser, Inc.20170—
+8K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+8K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K161669Waterlase ExpressBiolase, Inc.201621—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+8K152737Lite TouchFocus Medical, LLC20160—
+8K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K152611V20 systemViora, Ltd.20164—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—