510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172111Vevazz LEDVevazz, LLC20170—
+4K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+4K171702Exciplex308nmClarteis20175—
+4K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+4K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+4K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+4K162784Silk'n HSTHome Skinovations, Ltd.20171—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+4K160821Tria SapphireTria Beauty, Inc.20160—
+4K160368EVO platformQuanta System Spa201636—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152280BioPhotas Celluma3Biophotas, Inc.201649—
+4K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+4K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+4K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+4K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+4K150051ExiliteBTL Industries, Inc.20150—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K140471Pro X Otc 5La Lumiere, LLC2015107—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K101415TheraclearTheravant Corporation20101—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081570DPL Therapy SystemLed Technologies, LLC200811
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K070690The Life VesselCottonwood Vessel Corporation20070—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261473ChromixTermosalud S.L.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—