510(k) Report

Devices descending from K062321

182 later devices reach Smartlipo ND:Yag Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152737Lite TouchFocus Medical, LLC20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K131839DC 7Dc International, LLC20130—
+4K130465EPIC 10SBiolase Technology, Inc.20130—
+4K111689StlaseDental Photonics, Inc.201222—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K163128Epic ProBiolase, Inc.201716—
+5K152714Quanta ForteQuanta System Spa201513—
+5K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K192856MT OneM&T S.R.L.20202—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K172771Epic Pro 940Biolase, Inc.20171—
+6K172413MT ONEM&T S.R.L.20175—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K22079410PLTentech Co., Ltd.20220—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K200693K2 MobileHulaser, Inc.20202—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—