510(k) Report

Devices descending from K914136

1,315 later devices reach Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+9K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+9K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K223147myLEDmaskMyblend20234—
+9K223680Eneka ProTermosalud20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+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—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K212561MTX-C1Ilooda Co,., Ltd.20220—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+9K203013AGNESAgnes Medical Co., Ltd.20224—
+9K221083Smartlux MiniMedmix Co., Ltd.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+9K213534PHantom TrilogyResurgeonz, LLC20220—
+9K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+9K213814Viveve 2.0 SystemViveve, Inc.20220—
+9K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+9K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K210847UltraClear Fractional Laser SystemFa International, LP20210—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K202780SectumNeauvia North America20211—
+9K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+9K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+9K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+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—
+9K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K191086ExciplexClarteis20194—
+9K192224BTL-899Btl20198—
+9K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+9K190678TempSureCynosure, Inc.201914—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+9K183247dpl FacewareLed Technologies, Inc.201910—
+9K183118dpl SpotLiteLed Technologies, Inc.201922—
+9K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K180875Poly RejuvMedtek Skincare, LLC20180—
+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—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+9K1718212 Face / Face EvolutionHeat IN A Click201858—
+9K180406Ellipse YdunEllipse A/S20180—
+9K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+9K171262TempSureCynosure, Inc.201716—
+9K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+9K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+9K172004truSculptCutera, Inc.20173—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+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—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+9K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+9K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+9K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+9K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+9K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+9K151655CO2RE SystemSyneron Medical, Ltd.20151—