510(k) Report

Devices descending from K954013

1,233 later devices reach Trilase 2940 Erbium Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K170850Alma QAlma Lasers, Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+8K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K160821Tria SapphireTria Beauty, Inc.20160—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K160368EVO platformQuanta System Spa201636—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K152280BioPhotas Celluma3Biophotas, Inc.201649—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+8K152611V20 systemViora, Ltd.20164—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+8K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150035V10 systemViora, Ltd.201531—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K150051ExiliteBTL Industries, Inc.20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K141868Tria FanpTria Beauty, Inc.20140—
+8K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140120EPIC 10Biolase, Inc.20141—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+8K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K113588Spectra Laser SystemLutronic Corporation201282—
+8K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+8K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+8K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+8K101415TheraclearTheravant Corporation20101—
+8K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+8K091534Lightlas Model 532Lightmed Corp.200972—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+8K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+8K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+8K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+8K080932Mosaic Laser SystemLutronic Corporation20086—
+8K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+8K070392Mosaic Laser SystemLutronic Corporation20078—
+8K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+8K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+8K050218Wavelight SinonWavelight Laser Technologie AG20050—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K261473ChromixTermosalud S.L.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—