510(k) Report

Devices descending from K001179

701 later devices reach Super Nova, Acubeam through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+3K070690The Life VesselCottonwood Vessel Corporation20070—
+3K062256HF54 Combination Ultrasound Interferential and Premodulated Stimulation SystemHill Laboratories Co.20072—
+3K050668GRT Lite, Model 8-aGrt Solutions, Inc.20069—
+3K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+3K051680Dynatron DX2 Traction UnitDynatronics Corp.20050—
+3K051261Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeDynatronics Corp.20051—
+3K043353Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc.20051—
+3K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005239—
+3K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp.200513—
+3K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+3K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+3K040729Solaris D890 Therapy ProbeDynatronics Corp.200428—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K193008Tricoglam Home UseAdvihair S.R.L.20206—
+4K200616E>EyeCE-Swin20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20203—
+4K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20190—
+4K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20184—
+4K180508Joule SystemSciton, Inc20183—
+4K173729Revian RedPhotonmd, Inc.201819—
+4K171775Theradome LH80 PROTheradome, Inc.20181—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172413MT ONEM&T S.R.L.20175—
+4K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+4K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+4K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+4K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+4K152280BioPhotas Celluma3Biophotas, Inc.201649—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150716Varaya SportVaraya Photoceuticals, LLC20150—
+4K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+4K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc.201546—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K150175HeatLux Pro IHome Skinovations, Ltd.20151—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142025Neurolumen PN-1000Neurolumen, LLC20150—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K132057Dynatron Peltier Thermostim ProbeDynatronics Corp.20140—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K113017Sys*Stim 240Mettler Electronics Corp.20129—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+4K083595EzlaseBiolase Technology, Inc.200958—
+4K083202Combocare 2000Xanacare Technologies, LLC20082—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K072551LD-I 75 and LD-I 200Meditech International, Inc.20080—
+4K072256HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with…Hill Laboratories Co.20081—
+4K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+4K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512—
+4K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—