510(k) Report

Devices descending from K972347

1,142 later devices reach Modified Coherent Versapulse Aesthetic Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K170850Alma QAlma Lasers, Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+6K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+6K162784Silk'n HSTHome Skinovations, Ltd.20171—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+6K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+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—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+6K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+6K101415TheraclearTheravant Corporation20101—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K091534Lightlas Model 532Lightmed Corp.200972—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+6K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K070690The Life VesselCottonwood Vessel Corporation20070—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K050218Wavelight SinonWavelight Laser Technologie AG20050—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261473ChromixTermosalud S.L.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—