510(k) Report

Devices descending from K850668

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K121286EPIC 10Biolase Technology, Inc.201231—
+8K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+8K120513Glow by EndymedEndymed Medical, Ltd.20125—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+8K111689StlaseDental Photonics, Inc.201222—
+8K111026ApolloPollogen, Ltd.201114—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K111784Venus Swan SystemVenus Concept, Ltd.20111—
+8K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+8K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+8K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+8K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+8K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+8K101321Ematrix CO2Syneron Medical, Ltd.20102—
+8K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+8K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+8K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+8K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+8K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+8K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+8K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+8K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261473ChromixTermosalud S.L.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250165PastelleWontech Co., Ltd.20250—
+9K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K250125LMNT O2Xplr, Ltd.20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241102Luna 4 plusForeo, Inc.20245—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+9K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+9K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+9K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+9K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+9K230077LaserMENeauvia North America20232—
+9K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K223147myLEDmaskMyblend20234—
+9K223680Eneka ProTermosalud20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+9K221083Smartlux MiniMedmix Co., Ltd.20222—
+9K221571InMode Multi-systemInMode, Ltd.20222—
+9K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+9K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K213534PHantom TrilogyResurgeonz, LLC20220—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+9K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—