510(k) Report

Devices descending from K031671

678 later devices reach Polaris WR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193266MIINMedico USA, Inc.20210—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202041Opera EvoQuanta System Spa20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K200241TempSure SystemCynosure, LLC202013—
+7K193486Epic 980Biolase, Inc.20202—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K191086ExciplexClarteis20194—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180406Ellipse YdunEllipse A/S20180—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K163128Epic ProBiolase, Inc.201716—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K240780InMode RF SystemInMode, Ltd.20243—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K212891TempSure SystemCynosure, LLC20221—
+8K213344BTL-899ABTL Industries, Inc.20222—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+8K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K193426Elite iQCynosure, LLC20201—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K172771Epic Pro 940Biolase, Inc.20171—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—