510(k) Report

Devices descending from K950661

1,153 later devices reach Candela 10MM Circular Spot Laser Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K160368EVO platformQuanta System Spa201636—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+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—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+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—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+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—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+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—
+6K110370Q-ClearLight Age, Inc.201135—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+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
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+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—
+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—
+6K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+6K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+6K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+6K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+6K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+6K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+6K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+6K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+6K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+6K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+6K023881Profile 1064 Laser SystemSciton, Inc2003227—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+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—
+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—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K253007Laser 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—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—