510(k) Report

Devices descending from K932376

727 later devices reach Zeiss Opmilas 144 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K092734E-Light LineEspansione Marketing S.P.A20102—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K253765Vanish ProDdc Technologies, Inc.20260—
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260632Laser Thermal Therapy KitElesta S.P.A20260—
+8K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K252877SANDRO DualWontech Co., Ltd.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K244060eCO2 3DLutronic Corporation20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250165PastelleWontech Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+8K241527Pastelle ProWontech Co., Ltd.20253—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K223727LavieenWontech Co., Ltd.20234—
+8K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K230077LaserMENeauvia North America20232—
+8K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K221761SoleaConvergent Dental, Inc.202201
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K213594Echolaser X4Elesta S.P.A20221—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K213428EdgeProBiolase, Inc.20210—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K193201BTL-785FBtl20208—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K180406Ellipse YdunEllipse A/S20180—
+8K171702Exciplex308nmClarteis20175—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K160368EVO platformQuanta System Spa201636—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K152611V20 systemViora, Ltd.20164—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K150664NeoLasSheaumann Laser, Inc.20151—