510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+6K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+6K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+6K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+6K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+6K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+6K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+6K223727LavieenWontech Co., Ltd.20234—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230293TheraFace MaskTherabody, Inc.202316—
+6K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+6K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+6K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+6K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+6K223680Eneka ProTermosalud20230—
+6K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+6K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212155TheraFace LEDTheragun, Inc.202142—
+6K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+6K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+6K212238TheraFace MicrocurrentTheragun, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K193201BTL-785FBtl20208—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+6K190443MMSphereGalactic Beauty, LLC201942—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170984LG Beauty Led MaskLg Electronics201793—
+6K171227StarWalkerFotona D.O.O.20177—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160691Acne Light Therapy WandZuko, Inc.201650—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—