510(k) Report

Devices descending from K960036

440 later devices reach Firard II/ TDP Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081720Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsPrime Herbs Corporation20091—
+1K053376Chung Cheng Far Infrared Ray Healthful Lamp (or Medical Fir Radiator), Model CH-8810Chung Cheng Electric Heating Co., Ltd.20060—
+1K020851TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…C&H International2002314—
+1K013197WS-501 Heat LampLhasa Medical, Inc.2002151—
+2K162590Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd.20170—
+2K141892QK-Systemic Therapeutic ApparatusHarbin Quanke Medi-Technical Development Co., Ltd.20150—
+2K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+2K033183Reclear Phototherapy System, Model FGCM0012Curelight, Ltd.20040—
+2K024027Lightwave Infrared Lamps LW10D and LW30DSkytech Enterprises, Inc.20031—
+2K033035TLC Models Ulk-H and Ult-H Infrared LampsTlc Marketing, Inc.20030—
+2K024179Palomar LightcubePalomar Medical Products, Inc.2003308—
+3K090221Reaction SystemViora, Ltd.200954—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+3K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+3K071872VelashapeSyneron Medical, Ltd.2007127—
+3K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+3K061603SmoothshapesBiocellulase, Inc.200648—
+3K053611SmoothshapesBicellulase, Inc.200695—
+3K051961Wwmed, Model 401Wong Way Corporation20060—
+3K051046Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC200503
+3K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+3K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004294—
+3K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+4K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K143554Venus Legacy CXVenus Concept, Ltd.201517—
+4K150035V10 systemViora, Ltd.201531—
+4K141904Viora V-TouchViora, Ltd.20140—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K120510TranscendSyneron Medical, Ltd.201318—
+4K122579VelashapeSyneron Medical, Ltd.20124—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+4K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+4K083629SmoothshapesEleme Medical, Inc.200927—
+4K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+4K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+4K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+4K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+4K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+4K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+4K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005239—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+4K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K250852CoolfaseAsterasys Co., Ltd.20250—
+5K251327XERFLutronic Corporation202501
+5K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+5K242241SunnyShenB Co., Ltd.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K240248Volnewmer™Classys, Inc.20241—
+5K23299210THERMATentech, Inc.20230—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K221989The OligioWontech Co., Ltd.20222—
+5K212561MTX-C1Ilooda Co,., Ltd.20220—
+5K213524CytonPro-5000Cytonsys, Inc.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K202780SectumNeauvia North America20211—
+5K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K183450EmBody SystemInmode MD, Ltd.20198—
+5K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+5K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K162512truSculptCutera, Inc.20165—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K152611V20 systemViora, Ltd.20164—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K150466ZX2 Laser SystemLzr7, Inc.20150—
+5K142093V20 SystemViora, Ltd.201432—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K111501I-Lipo SystemChromogenex Technologies Limited201215—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+5K083595EzlaseBiolase Technology, Inc.200958—
+5K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—