510(k) Report

Devices descending from K003538

447 later devices reach TDP CQ-27 Heat Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110721Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd.20110—
+1K081720Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsPrime Herbs Corporation20091—
+1K080465WS Far Infrared Therapy Unit, Model # TY-101 SeriesWs Far IR Medical Technology Co., Ltd.20081—
+1K061080IR PRO 250Lhasa Oms, Inc.20060—
+1K052063Huanqiu Heating LampA & A Medical Supplies, Inc.20050—
+1K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+1K043558Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55AChongqing Xinfeng Medical Instruments Co., Ltd.20054—
+1K024179Palomar LightcubePalomar Medical Products, Inc.2003308—
+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—
+2K160849WS (TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd.20160—
+2K141892QK-Systemic Therapeutic ApparatusHarbin Quanke Medi-Technical Development Co., Ltd.20150—
+2K101693Gaunying Infrared Lamp Model IL50Foshan Gaunying Electronics Co., Ltd.20110—
+2K102149Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd.20101—
+2K090221Reaction SystemViora, Ltd.200954—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+2K071872VelashapeSyneron Medical, Ltd.2007127—
+2K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+2K061603SmoothshapesBiocellulase, Inc.200648—
+2K053611SmoothshapesBicellulase, Inc.200695—
+2K051961Wwmed, Model 401Wong Way Corporation20060—
+2K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+2K033183Reclear Phototherapy System, Model FGCM0012Curelight, Ltd.20040—
+2K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004294—
+2K024027Lightwave Infrared Lamps LW10D and LW30DSkytech Enterprises, Inc.20031—
+2K033035TLC Models Ulk-H and Ult-H Infrared LampsTlc Marketing, Inc.20030—
+2K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+3K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K143554Venus Legacy CXVenus Concept, Ltd.201517—
+3K150035V10 systemViora, Ltd.201531—
+3K141904Viora V-TouchViora, Ltd.20140—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122579VelashapeSyneron Medical, Ltd.20124—
+3K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+3K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K083629SmoothshapesEleme Medical, Inc.200927—
+3K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+3K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+3K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+3K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+3K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+3K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+3K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005239—
+3K051046Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC200503
+3K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+3K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+4K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+4K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K212561MTX-C1Ilooda Co,., Ltd.20220—
+4K213524CytonPro-5000Cytonsys, Inc.20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K202780SectumNeauvia North America20211—
+4K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K190743Venus BlissVenus Concept USA, Inc.20194—
+4K183450EmBody SystemInmode MD, Ltd.20198—
+4K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+4K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+4K170637sensiFirmEl Global Trade, Ltd.20173—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161043Profound SystemSyneron Candela Corporation20160—
+4K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+4K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+4K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+4K153568InMode Plus SystemInmode MD, Ltd.201618—
+4K152611V20 systemViora, Ltd.20164—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K150466ZX2 Laser SystemLzr7, Inc.20150—
+4K142093V20 SystemViora, Ltd.201432—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—