510(k) Report

Devices descending from K964736

979 later devices reach Bergen 610 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253342PICO-KSpeclipse, Inc.20251—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250165PastelleWontech 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—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K250125LMNT O2Xplr, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+8K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+8K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+8K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+8K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K223147myLEDmaskMyblend20234—
+8K223680Eneka ProTermosalud20230—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+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—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+8K221083Smartlux MiniMedmix Co., Ltd.20222—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+8K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K193201BTL-785FBtl20208—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K191086ExciplexClarteis20194—
+8K192430Epic 980Biolase, Inc.20195—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183247dpl FacewareLed Technologies, Inc.201910—
+8K183118dpl SpotLiteLed Technologies, Inc.201922—
+8K180359BTL-FR2000BTL Industries, Inc.20189—
+8K180875Poly RejuvMedtek Skincare, LLC20180—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+8K1718212 Face / Face EvolutionHeat IN A Click201858—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K173759Thermage CPT System and AccessoriesSolta Medical201821
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170758Thermage FLX System and AccessoriesSolta Medical201713—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K170068Softcure 96Wellray Medical Laser, Inc.20170—
+8K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+8K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—