510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+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—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+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—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140120EPIC 10Biolase, Inc.20141—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K131758Surgen UPollogen, Ltd.20135—
+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—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+6K101415TheraclearTheravant Corporation20101—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+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—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K070690The Life VesselCottonwood Vessel Corporation20070—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+6K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+6K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+6K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—