510(k) Report

Devices descending from K000072

697 later devices reach Dornier Medilas D Skinpulse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+6K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+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—
+6K202041Opera EvoQuanta System Spa20200—
+6K193201BTL-785FBtl20208—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193486Epic 980Biolase, Inc.20202—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K200234Surgical laser fibersQuanta System Spa20202—
+6K191086ExciplexClarteis20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K163197Cook Holmium Laser FiberCook Incorporated20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163128Epic ProBiolase, Inc.201716—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+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—
+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—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081408Ellipse MultiflexEllipse A/S20087—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics 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—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., 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—
+7K250852CoolfaseAsterasys 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—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+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—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+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—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K243488Vmat ProTermosalud20250—