510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+6K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+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—
+6K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+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—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+6K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+6K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+6K223727LavieenWontech Co., Ltd.20234—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230293TheraFace MaskTherabody, Inc.202316—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+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—
+6K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+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—
+6K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+6K212155TheraFace LEDTheragun, Inc.202142—
+6K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K212238TheraFace MicrocurrentTheragun, Inc.20210—
+6K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190443MMSphereGalactic Beauty, LLC201942—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K170984LG Beauty Led MaskLg Electronics201793—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160691Acne Light Therapy WandZuko, Inc.201650—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140120EPIC 10Biolase, Inc.20141—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—