510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+8K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+8K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+8K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+8K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+8K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+8K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+8K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+8K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+8K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K213261EpilMENeauvia North America20220—
+8K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+8K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd.20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+8K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+8K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170850Alma QAlma Lasers, Ltd.20172—
+8K170908PK AIMGyrus Acmi, Inc.20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161038PK MorcellatorGyrus Acmi, Inc.20160—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160691Acne Light Therapy WandZuko, Inc.201650—
+8K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+8K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+8K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—