510(k) Report

Devices descending from K960032

1,152 later devices reach Coherent Versapulse Aesthetic Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160368EVO platformQuanta System Spa201636—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110370Q-ClearLight Age, Inc.201135—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K101415TheraclearTheravant Corporation20101—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+5K081570DPL Therapy SystemLed Technologies, LLC200811
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+5K070690The Life VesselCottonwood Vessel Corporation20070—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+5K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+5K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+5K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+5K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+5K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+5K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+5K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+5K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+5K023881Profile 1064 Laser SystemSciton, Inc2003227—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K261473ChromixTermosalud S.L.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—