510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K221761SoleaConvergent Dental, Inc.202201
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K213428EdgeProBiolase, Inc.20210—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191086ExciplexClarteis20194—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183566CLARITY II Laser SystemLutronic Corporation201911
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K152611V20 systemViora, Ltd.20164—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150035V10 systemViora, Ltd.201531—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131758Surgen UPollogen, Ltd.20135—
+7K131839DC 7Dc International, LLC20130—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—