510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K121435Silkn BlueHome Skinovations, Ltd.2013125—
+3K122237Biophotas LifelightBiophotas, Inc.201371—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111286Quasar CalypsoSilver Bay, LLC201276—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K110301Silk'n FXHome Skinovations, Ltd.201166—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+3K103415Tanda MaxPharos Life Corporation20110—
+3K100628PlasmaluxlsDaavlin Distributing Co.20100—
+3K091467Baby QuasarSilver Bay, LLC20100—
+3K093168Mediflash and EsteflashDermeo20100—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090744CLAROClrs Technology Corporation20101—
+3K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+3K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+3K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+3K090399Trios SystemViora, Ltd.20090—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083730IsolazAesthera Corporation20093—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+3K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+3K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+4K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+4K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+4K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K192275invisa-RED ELITEIR Technology, LLC20201—
+4K200616E>EyeCE-Swin20200—
+4K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—