510(k) Report

Devices descending from K951033

1,265 later devices reach Andela Dynamic Cooling Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+3K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K060948Portrait PSR3Rhytec Incorporated20061101
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K043032Dealight IplEuropro, Inc.20050—
+3K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K051255Lumiphase-ROpusmed, Inc.2005143—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K040135Thermage Thermacool SystemThermage, Inc.2004496—
+3K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K033933Powerlite 600 EX SystemPreswede AB20040—
+3K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+3K031988Aurora DSSyneron Medical, Ltd.2003450—
+3K031993Aurora SRSyneron Medical, Ltd.2003303—
+3K031046Thermacool TC SystemThermage, Inc.200322—
+3K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+3K024064Polaris DSSyneron Medical, Ltd.2003681—
+3K030142Thermacool TC SystemThermage, Inc.2003773—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) 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—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222556BTL-785XBTL Industries, Inc.20235—
+4K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+4K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K211639BTL-785WBTL Industries, Inc.20227—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192621Medical RFTriworks Group Srl20200—
+4K193201BTL-785FBtl20208—
+4K200616E>EyeCE-Swin20200—
+4K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191693BC-5Reveallux, Corp20190—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+4K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+4K180508Joule SystemSciton, Inc20183—
+4K180584Viveve RF System, SecureViveve, Inc.20185—
+4K173285Joule SystemSciton, Inc20185—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K172413MT ONEM&T S.R.L.20175—
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K171227StarWalkerFotona D.O.O.20177—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K170116Thermi Injectable RF ElectrodesThermi20172—
+4K163190InMode RF SystemInmode MD, Ltd.20160—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K161043Profound SystemSyneron Candela Corporation20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—