510(k) Report

Devices descending from K022266

705 later devices reach Aurora SR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+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—
+4K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+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—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+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—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K192275invisa-RED ELITEIR Technology, LLC20201—
+4K200616E>EyeCE-Swin20200—
+4K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+4K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K180338CellulizeWard Photonics, LLC20182—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K181659Avologi ENEOPremier North America, Inc.20184—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+4K180508Joule SystemSciton, Inc20183—
+4K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+4K180320dpl IIa PanelLed Technologies, Inc.201814—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172111Vevazz LEDVevazz, LLC20170—
+4K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+4K171702Exciplex308nmClarteis20175—
+4K172413MT ONEM&T S.R.L.20175—
+4K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+4K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+4K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+4K162784Silk'n HSTHome Skinovations, Ltd.20171—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K152280BioPhotas Celluma3Biophotas, Inc.201649—
+4K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+4K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+4K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+4K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K140471Pro X Otc 5La Lumiere, LLC2015107—
+4K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—