510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K210847UltraClear Fractional Laser SystemFa International, LP20210—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+9K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+9K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+9K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+9K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+9K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K193201BTL-785FBtl20208—
+9K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+9K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+9K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+9K191086ExciplexClarteis20194—
+9K192430Epic 980Biolase, Inc.20195—
+9K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+9K183247dpl FacewareLed Technologies, Inc.201910—
+9K183118dpl SpotLiteLed Technologies, Inc.201922—
+9K180359BTL-FR2000BTL Industries, Inc.20189—
+9K180875Poly RejuvMedtek Skincare, LLC20180—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+9K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+9K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+9K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+9K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+9K1718212 Face / Face EvolutionHeat IN A Click201858—
+9K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+9K173759Thermage CPT System and AccessoriesSolta Medical201821
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K170758Thermage FLX System and AccessoriesSolta Medical201713—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K170068Softcure 96Wellray Medical Laser, Inc.20170—
+9K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+9K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+9K163128Epic ProBiolase, Inc.201716—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+9K160312Fraxis DuoIlooda Co,., Ltd.201614—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K160075Accent XLAlma Lasers, Inc.20160—
+9K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+9K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+9K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+9K151655CO2RE SystemSyneron Medical, Ltd.20151—
+9K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+9K142860Lumenis M22 SystemLumenis, Ltd.2015381
+9K141868Tria FanpTria Beauty, Inc.20140—
+9K142910Legacy BXVenus Concept USA, Inc.201411—
+9K142093V20 SystemViora, Ltd.201432—
+9K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+9K133364Picosure WorkstationCynosure, Inc.201451—
+9K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+9K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+9K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+9K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+9K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K120510TranscendSyneron Medical, Ltd.201318—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K122966XP200Btl Industries, Ltd.20131—
+9K121346Picosure WorkstationCynosure, Inc.201287—
+9K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+9K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+9K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+9K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+9K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+9K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+9K081408Ellipse MultiflexEllipse A/S20087—
+10K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+10K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+10K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—