510(k) Report

Devices descending from K001179

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+1K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+1K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+1K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc.20058—
+1K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+1K042532Biocare Systems Premir 818Biocare Systems, Inc.20048—
+1K042256IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and…Usa Laser Biotech, Inc.20047—
+1K033183Reclear Phototherapy System, Model FGCM0012Curelight, Ltd.20040—
+1K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+1K032816Quantum Light Therapy SystemStargate International, Inc.200473—
+1K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+1K023621Bioflex Professional Therapy SystemMeditech International, Inc.2003311—
+1K020017Medx 1000 SeriesMedx Electronics, Inc.2002187—
+2K150466ZX2 Laser SystemLzr7, Inc.20150—
+2K132016Lumix 3 Plus and Lumix 3 Ultra SystemTexas Applied Biomedical Services, Inc.20143—
+2K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+2K112016L-Ser KO LampYa-Man, Ltd.20120—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Usa Laser Biotech, Inc.20115—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC201058—
+2K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc.20096—
+2K090008Tanda Restore, Model PtscsPharos Life Corporation20096—
+2K083822Laser TouchoneLaser Health Technologies, LLC20091—
+2K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K061656Laser-D68Laser Pain Clinics LP20065—
+2K060792IllumimedPhotoactif, LLC2006115—
+2K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+2K051816Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc.200531
+2K051631Excalibur IV Light Therapy System, Model SGEX4-001Stargate International, Inc.20050—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+2K050022Medx HomeMedx Electronics, Inc.20050—
+2K030275MB System, Bioenergy Light TherapyAmest Corp.20040—
+2K041530Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc.200412—
+2K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004294—
+2K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Dynatronics Corp.200337—
+2K032231MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable LaserMedx Electronics, Inc.200374—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213524CytonPro-5000Cytonsys, Inc.20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+3K170068Softcure 96Wellray Medical Laser, Inc.20170—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K162763Vevazz LED Heat LampVevazz, LLC20170—
+3K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+3K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K151629Guardian 1000Quanta System Spa20150—
+3K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+3K151516Capillus82Capillus, LLC201524—
+3K142824LX-100 Hair Growth Stimulation SystemHairlabs International, Inc.20150—
+3K141237Harmony LiteAlma, Inc.20154—
+3K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K132646Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC20133—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+3K122950Laser HelmetTheradome, Inc.201346—
+3K122237Biophotas LifelightBiophotas, Inc.201371—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K120835Dynatron Thermostim Probe-DoneDynatronics Corporation20121—
+3K120582HeatluxHome Skinovations, Ltd.20123—
+3K120604K-LaserEltech S.R.L20124—
+3K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC20121—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K113097Laser HelmetTheradome, Inc.201257—
+3K113250Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp.20120—
+3K111286Quasar CalypsoSilver Bay, LLC201276—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+3K073681Nanobeam 940, Model 940-900-02Davaray, Inc.20080—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081570DPL Therapy SystemLed Technologies, LLC200811
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K082707Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc.200859—
+3K081141Combocare 2000Xanacare Technologies, LLC20086—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—