510(k) Report

Devices descending from K982082

424 later devices reach Handisol Wound Healing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043377ZENOTyrell, Inc.2005142—
+1K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280—
+2K170489Skylit Phototherapy SystemSkylit Medical20175—
+2K111341Cleane / Cleane PopMedicon Co., Ltd.20120—
+2K111937Clearflash AC2100 Cosmetic SystemClearflash Technologies, Inc.20120—
+2K090744CLAROClrs Technology Corporation20101—
+2K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+2K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+2K080591Tanda Skincare System, Model: PtscsPharos Life Corporation2008137—
+2K080638CLAROClrs Technology Corporation20082—
+2K060653ThermaclearDermacare, Inc.2006132—
+2K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274—
+3K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+3K173436Luma Light SystemLuma Therapeutics20183—
+3K171702Exciplex308nmClarteis20175—
+3K160821Tria SapphireTria Beauty, Inc.20160—
+3K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+3K132838Nutra Light BlueNutra Luxe MD, LLC20142—
+3K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K124042Tanda Mini Skincare SystemSyneron Beauty201376—
+3K121435Silkn BlueHome Skinovations, Ltd.2013125—
+3K091125Clearwave Phototherapy System for Acne, Model: CWST2Verilux20100—
+3K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K073066308 Dermatological Excimer SystemQuantel Medical, Inc.20076—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191086ExciplexClarteis20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+4K180320dpl IIa PanelLed Technologies, Inc.201814—
+4K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+4K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC20160—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160691Acne Light Therapy WandZuko, Inc.201650—
+4K153229SuperbiumBios S.R.L.20162—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+4K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K150370Nutra Light AdvancedNutra Luxe MD, LLC20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K241102Luna 4 plusForeo, Inc.20245—
+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—
+5K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+5K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+5K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K210948Omnilux CLEARGlobalmed Technologies202139—
+5K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K200616E>EyeCE-Swin20200—
+5K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K183247dpl FacewareLed Technologies, Inc.201910—
+5K180875Poly RejuvMedtek Skincare, LLC20180—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K180508Joule SystemSciton, Inc20183—
+5K1718212 Face / Face EvolutionHeat IN A Click201858—
+5K173285Joule SystemSciton, Inc20185—