510(k) Report

Devices descending from K974536

1,496 later devices reach Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+3K053324Chromolite SystemChromogenex Plc200631—
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+3K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+3K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K031988Aurora DSSyneron Medical, Ltd.2003450—
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K030480L600 Hair RemovalA&M Technology20031—
+3K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+3K024064Polaris DSSyneron Medical, Ltd.2003681—
+3K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+3K022607SpectrapulsePrimary Technology, LLC20020—
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K22079410PLTentech Co., Ltd.20220—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+4K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192621Medical RFTriworks Group Srl20200—
+4K200616E>EyeCE-Swin20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+4K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+4K180508Joule SystemSciton, Inc20183—
+4K180224Element-TLElemenic Co., Ltd.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K172181micro IPLEl Global Trade, Ltd.20170—
+4K172413MT ONEM&T S.R.L.20175—
+4K171227StarWalkerFotona D.O.O.20177—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K170269Hee HR MiniOriental Inspiration Limited201713—