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
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171702Exciplex308nmClarteis20175—
+6K172413MT ONEM&T S.R.L.20175—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130199Clarity LPC Laser SystemLutronic Corporation20135—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K102461FractoraInvasix, Ltd.201124—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+6K080374Biosyag Medical SystemBios S.R.L.20082—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+6K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+6K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—