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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- K252273Therapy US2Cleared 510(K)
- K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)2Cleared 510(K)
- K232813Therapy EC, Therapy XT2Cleared 510(K)
- K231409Erchonia FX-4052Cleared 510(K)
- K212189FibroLux2Cleared 510(K)
- K221987Erchonia GVL2Cleared 510(K)
- K203337PainTB, PainTJ2Cleared 510(K)
- K212595Erchonia FX-4052Cleared 510(K)
- K211186Erchonia XLR82Cleared 510(K)
- K191257Erchonia EVRL2Cleared 510(K)
- K190572Erchonia FX-6352Cleared 510(K)
- K180197Erchonia FX-6352Cleared 510(K)
- K180585Collagentex Rx-62Cleared 510(K)
- K171354MR4 Laser2Cleared 510(K)
- K162022Collagentex Rx-12Cleared 510(K)
- K152196Erchonia EVRL2Cleared 510(K)
- K153052Erchonia PL Touch2Cleared 510(K)
- K151816TLC-2000 Therapeutic Medical Laser System2Cleared 510(K)
- K132940ERCHONIA ALLAY2Cleared 510(K)
- K130996ERCHONIA EMERGE2Cleared 510(K)
- K130741ERCHONIA PL50002Cleared 510(K)
- K101430MLS-AC DERMA SCANNER2Cleared 510(K)
- K100509THL1 LASER2Cleared 510(K)
- K081166LIGHTSTREAM LOW LEVEL LASER2Cleared 510(K)
- K080513QLASER SYSTEM2Cleared 510(K)
- K073689LEP2000 THERAPY SYSTEM2Cleared 510(K)
- K072206ERCHONIA EML LASER2Cleared 510(K)
- K072551LD-I 75 AND LD-I 2002Cleared 510(K)
- K063574LUMINEX LL LASER SYSTEM2Cleared 510(K)
- K053507ELITE ELECTROMED L.I.T.E. 4/12Cleared 510(K)
- K050668GRT LITE, MODEL 8-A2Cleared 510(K)
- K051631EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-0012Cleared 510(K)
- K050342THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM2Cleared 510(K)
- K043353OMEGA EXCEL/XP LASER SYSTEM2Cleared 510(K)
- K041565LAZRPULSR 4X2Cleared 510(K)
- K034009LAPEX 20002Cleared 510(K)
- K041530EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-0012Cleared 510(K)
- K041139ERCHONIA EML LASER2Cleared 510(K)
- K032816QUANTUM LIGHT THERAPY SYSTEM2Cleared 510(K)
- K023060ACCULASER PRO42Cleared 510(K)
- K032216BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM2Cleared 510(K)
- K033015AXIOM BIOLASER LLLT SERIES-32Cleared 510(K)
- K031499DIOBEAM 8302Cleared 510(K)
- K030622AXIOM BIOLASER LLLT SERIES-12Cleared 510(K)
- K030692POWER LASER 902Cleared 510(K)
- K024310NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY2Cleared 510(K)
- K030226THOR DDII 830CL3 LASER SYSTEM2Cleared 510(K)
- K023935TRILUMINA THERAPEUTIC LASER SYSTEM2Cleared 510(K)
- K021985MEDX LCS LASER SERIES2Cleared 510(K)
- K020657ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE2Cleared 510(K)
- K010175MICROLIGHT 830 LASER SYSTEM2Cleared 510(K)
- K012580ERCHONIA PL20002Cleared 510(K)
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- SGTElectromagnetic Stimulator For Healthy Muscle Stimulation2Product Code
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TLC-2000 Therapeutic Medical Laser System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K151816
- 510(k) Type
- Traditional
- Applicant
- Theralase, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/19/2015
- Days to Decision
- 136 days
- Submission Type
- Statement