welcome introduction to laser physics safety, tissue interaction, & fda claims and labeling...

WelcomeWelcome

Introduction to Laser Physics Introduction to Laser Physics Safety, Tissue Interaction, & Safety, Tissue Interaction, &

FDA Claims and LabelingFDA Claims and Labeling

Michael M. BarbourMichael M. Barbour

MicroLight Corporation of AmericaMicroLight Corporation of America

Founder and President Founder and President

BiographyBiography

Houston Laser Institute-1980 to 1990Houston Laser Institute-1980 to 1990Microlight Corporation of America-1990Microlight Corporation of America-1990American Society of Laser Therapy-1991American Society of Laser Therapy-1991Patent-1993Patent-1993General Motors Study-1996General Motors Study-1996Baylor College of Medicine-2000Baylor College of Medicine-2000F.D.A. Clearance -2002F.D.A. Clearance -2002Education/ Research-2007Education/ Research-2007

HISTORYHISTORY

EinsteinEinstein

Bell LabsBell Labs

MesterMester

TERMINOLOGYTERMINOLOGY

NanometersNanometers

MilliwattsMilliwatts

PhotonsPhotons

JoulesJoules

Super PulseSuper Pulse

Continuous Continuous WaveWave

DiodeDiode

ELECTROMAGNETIC SPECTRUMELECTROMAGNETIC SPECTRUM

LASERSLASERS

MonochromaticMonochromatic

CoherentCoherent

CollimatedCollimated

SunlightSunlight

LEDLED (light emitting diode)(light emitting diode)

830Laser Produces 830Laser Produces

a Unique Lighta Unique Light MonochromaticMonochromatic CoherentCoherent CollumatedCollumated

WAVEFORMSWAVEFORMS

LASER TISSUE ABSORPTIONLASER TISSUE ABSORPTION

Inflammation ReductionInflammation Reduction

Pain ReductionPain Reduction

Reduced Healing TimeReduced Healing Time

LASER CLASSIFICATIONSLASER CLASSIFICATIONS

Class IIIaClass IIIa

Class IIIbClass IIIb

Class IVClass IV

Class III aClass III a

635 nm635 nm5 mw 5 mw Under FDA Under FDA ReviewReview

ERCHONIAERCHONIA

Class III bClass III b

830 nm830 nm

90 mw90 mw

Patented Patented

Class IV Class IV

1 watt of energy1 watt of energy

Cut, vaporize, or coagulateCut, vaporize, or coagulate

Class III aClass III a

Bar CodeBar Code

Laser PointerLaser Pointer

MedicalMedical

Class III bClass III b

MilitaryMilitary

ConsumerConsumer

MedicalMedical

Class IVClass IV

LasikLasik

Hair RemovalHair Removal

WrinklesWrinkles

Brain StrokesBrain Strokes

L.E.D.’sL.E.D.’s

NanometersNanometers

MilliwattsMilliwatts

Heats TissueHeats Tissue

Not a LaserNot a Laser

880 nm880 nm

500 mw500 mw

Sports MedicineSports Medicine

ML830 Laser ML830 Laser Direct Connect LaserDirect Connect Laser 830nm probe830nm probe A/C cordA/C cord Laser GlassesLaser Glasses CaseCase

Portable Battery LaserPortable Battery Laser 830nm Probe830nm Probe 3 lithium batteries3 lithium batteries Charger and power meterCharger and power meter Laser GlassesLaser Glasses CasesCases

FDA letterheadFDA letterhead

ILY-Infrared Heating LampILY-Infrared Heating LampNHN-Non Heating Infrared LampNHN-Non Heating Infrared LampFDA Warning LetterFDA Warning Letter

StudiesStudiesTreatment of repetitive use carpal tunnel syndrome Smith CF, Vangsness CT, Anderson T & Good W (1995)Proceedings SPINE (1995) 2395; 658-661.

Noninvasive laser neurolysis in carpal tunnel syndrome Weintraub MI, MD, FACP Muscle Nerve (1997) 20:1029-1031.

Comparison between low level laser therapy, transcutaneous electro-neural stimulation, visible incoherent polarised light and placebo in the treatment of lateral epicondylitis: A pilot clinical study on 120 patients Simunovic Z and Trobonjaca T Lasers in Surgery and Medicine (2002) Supplement 14, Atlanta, Georgia

Efficacy of low power laser therapy in fibromyalgia: a single-blind, placebo-controlled trial Gur A, Karakoc M, Nas K, Cevik R, Sarac J, Demir E. Lasers in Medical Science (2002) 17(1):57-61.

StudiesStudiesThe clinical efficacy of low-power laser therapy on pain and function in cervical osteoarthritis. Oezdemir F, Birtane M, Kokino S Clinical Rheumatology (2001) 20(3): 181-184

Low level laser therapy for tendinopathy. Evidence of a dose-response pattern Bjordal J M, Couppe´ C, Ljunggren E Physical Therapy Reviews (2001) 6: 91-99

Low Level Laser Therapy For Trigger Point Release. Clinical Report on 11,000 trigger point releases using the ML830 Laser. Benard E. Filner Board Certified Anesthesiologists. Pain Management (2006) 10-Volume 6 Issue 7.

SUMMARY

HistoryHistoryTerminologyTerminologyLasersLasersL.E.D.’sL.E.D.’sFDA Claims and LabelingFDA Claims and LabelingReview of the Literature Review of the Literature

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