510(k) Report

Devices descending from K961748

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160821Tria SapphireTria Beauty, Inc.20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K160368EVO platformQuanta System Spa201636—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+7K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+7K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20153—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K141868Tria FanpTria Beauty, Inc.20140—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+7K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+7K101415TheraclearTheravant Corporation20101—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K091534Lightlas Model 532Lightmed Corp.200972—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+7K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+7K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+7K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+7K070392Mosaic Laser SystemLutronic Corporation20078—
+7K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+7K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+7K050218Wavelight SinonWavelight Laser Technologie AG20050—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K261473ChromixTermosalud S.L.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—