510(k) Report

Devices descending from K952661

339 later devices reach SLT Thermalite Diode Laser Series, Diode 980, 810, 940 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260976NeuroBlate SystemMonteris Medical20261—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+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—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T 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—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202041Opera EvoQuanta System Spa20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K193486Epic 980Biolase, Inc.20202—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K172771Epic Pro 940Biolase, Inc.20171—
+7K171227StarWalkerFotona D.O.O.20177—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152714Quanta ForteQuanta System Spa201513—
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+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—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—