510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183247dpl FacewareLed Technologies, Inc.201910—
+8K182173Joule SystemSciton, Inc20195—
+8K183118dpl SpotLiteLed Technologies, Inc.201922—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+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—
+8K180875Poly RejuvMedtek Skincare, LLC20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181510Echolaser X4El.En Electronic Engineering Spa20183—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+8K1718212 Face / Face EvolutionHeat IN A Click201858—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K171648BM.IrisBluecore Co., Ltd.20172—
+8K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170068Softcure 96Wellray Medical Laser, Inc.20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+8K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+8K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K161669Waterlase ExpressBiolase, Inc.201621—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+8K152737Lite TouchFocus Medical, LLC20160—
+8K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+8K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+8K140837Lucid LYBio-Med USA, Inc.20140—
+8K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+8K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+8K131839DC 7Dc International, LLC20130—
+8K123573Youlaser CO2 LaserQuanta System Spa201319—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K123889Acleara, TheraclearTheravant Corporation20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+8K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+8K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+8K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K091115ECO2 Laser SystemLutronic Corporation200927—
+8K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+8K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+8K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+8K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+8K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260632Laser Thermal Therapy KitElesta S.P.A20260—
+9K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+9K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—