510(k) Report

Devices descending from K052324

456 later devices reach Polaris LV, Lva Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K200693K2 MobileHulaser, Inc.20202—
+6K202172StarWalkerFotona D.O.O.20203—
+6K202041Opera EvoQuanta System Spa20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193486Epic 980Biolase, Inc.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K200234Surgical laser fibersQuanta System Spa20202—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K191086ExciplexClarteis20194—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163197Cook Holmium Laser FiberCook Incorporated20170—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163128Epic ProBiolase, Inc.201716—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160368EVO platformQuanta System Spa201636—
+6K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+6K152012EVO platformQuanta System Spa201537—
+6K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+7K201773PicohiHironic Co., Ltd.20215—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—