510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K192728AgnesAgnes Medical Co., Ltd.20196—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+8K182365TempSure SystemCynosure, Inc.201815—
+8K180338CellulizeWard Photonics, LLC20182—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K180508Joule SystemSciton, Inc20183—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K172413MT ONEM&T S.R.L.20175—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+8K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+8K162512truSculptCutera, Inc.20165—
+8K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K152280BioPhotas Celluma3Biophotas, Inc.201649—
+8K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+8K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+8K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+8K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+8K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+8K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+8K143554Venus Legacy CXVenus Concept, Ltd.201517—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+8K150035V10 systemViora, Ltd.201531—
+8K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K142910Legacy BXVenus Concept USA, Inc.201411—
+8K141904Viora V-TouchViora, Ltd.20140—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+8K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+8K133837Viora V-TotalViora, Ltd.201433—
+8K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K131758Surgen UPollogen, Ltd.20135—
+8K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+8K130459Tria Fan SystemTria Beauty, Inc.20131—
+8K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+8K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+8K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K122579VelashapeSyneron Medical, Ltd.20124—
+8K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+8K101321Ematrix CO2Syneron Medical, Ltd.20102—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K100558Quanta Diode Laser SystemQuanta System Spa201068—