510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K063249BeamaxMedic Sharplight, Ltd.200758—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K053324Chromolite SystemChromogenex Plc200631—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+4K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+4K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+4K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+4K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+4K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+4K023881Profile 1064 Laser SystemSciton, Inc2003227—
+4K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+4K030480L600 Hair RemovalA&M Technology20031—
+4K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+4K024064Polaris DSSyneron Medical, Ltd.2003681—
+4K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+4K022607SpectrapulsePrimary Technology, LLC20020—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K22079410PLTentech Co., Ltd.20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+5K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192621Medical RFTriworks Group Srl20200—
+5K200616E>EyeCE-Swin20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+5K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+5K180508Joule SystemSciton, Inc20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K173285Joule SystemSciton, Inc20185—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K172181micro IPLEl Global Trade, Ltd.20170—
+5K172413MT ONEM&T S.R.L.20175—