510(k) Report

Devices descending from K012398

714 later devices reach Diomed 15 Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191942MT One DiamondM&T S.R.L.20191—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163128Epic ProBiolase, Inc.201716—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+6K122966XP200Btl Industries, Ltd.20131—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K081408Ellipse MultiflexEllipse A/S20087—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+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—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+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—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.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—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+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—
+7K251327XERFLutronic Corporation202501
+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—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) 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—
+7K242241SunnyShenB Co., Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K23299210THERMATentech, Inc.20230—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230663DensityJeisys Medical, Inc.20232—
+7K221865BTL-094BTL Industries, Inc.20230—