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

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Welcome Welcome Introduction to Laser Introduction to Laser Physics Safety, Tissue Physics Safety, Tissue Interaction, & FDA Claims Interaction, & FDA Claims and Labeling and Labeling Michael M. Barbour Michael M. Barbour MicroLight Corporation of America MicroLight Corporation of America Founder and President Founder and President

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Page 1: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

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

Page 2: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

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

Page 3: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

HISTORYHISTORY

EinsteinEinstein

Bell LabsBell Labs

MesterMester

Page 4: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

TERMINOLOGYTERMINOLOGY

NanometersNanometers

MilliwattsMilliwatts

PhotonsPhotons

JoulesJoules

Super PulseSuper Pulse

Continuous Continuous WaveWave

DiodeDiode

Page 5: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

ELECTROMAGNETIC SPECTRUMELECTROMAGNETIC SPECTRUM

Page 6: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

LASERSLASERS

MonochromaticMonochromatic

CoherentCoherent

CollimatedCollimated

Page 7: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

SunlightSunlight

LEDLED (light emitting diode)(light emitting diode)

830Laser Produces 830Laser Produces

a Unique Lighta Unique Light MonochromaticMonochromatic CoherentCoherent CollumatedCollumated

WAVEFORMSWAVEFORMS

Page 8: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

LASER TISSUE ABSORPTIONLASER TISSUE ABSORPTION

Page 9: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Inflammation ReductionInflammation Reduction

Page 10: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Pain ReductionPain Reduction

Page 11: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Reduced Healing TimeReduced Healing Time

Page 12: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

LASER CLASSIFICATIONSLASER CLASSIFICATIONS

Class IIIaClass IIIa

Class IIIbClass IIIb

Class IVClass IV

Page 13: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class III aClass III a

635 nm635 nm5 mw 5 mw Under FDA Under FDA ReviewReview

ERCHONIAERCHONIA

Page 14: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class III bClass III b

830 nm830 nm

90 mw90 mw

Patented Patented

Page 15: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class IV Class IV

1 watt of energy1 watt of energy

Cut, vaporize, or coagulateCut, vaporize, or coagulate

Page 16: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class III aClass III a

Bar CodeBar Code

Laser PointerLaser Pointer

MedicalMedical

Page 17: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class III bClass III b

MilitaryMilitary

ConsumerConsumer

MedicalMedical

Page 18: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Class IVClass IV

LasikLasik

Hair RemovalHair Removal

WrinklesWrinkles

Brain StrokesBrain Strokes

Page 19: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder
Page 20: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder
Page 21: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

L.E.D.’sL.E.D.’s

NanometersNanometers

MilliwattsMilliwatts

Heats TissueHeats Tissue

Not a LaserNot a Laser

880 nm880 nm

500 mw500 mw

Page 22: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Sports MedicineSports Medicine

Page 23: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

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

Page 24: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

FDA letterheadFDA letterhead

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

Page 25: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

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.

Page 26: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

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.

Page 27: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

SUMMARY

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

Page 28: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Visit us at:Visit us at:www.ml830.comwww.ml830.com

Page 29: Welcome Introduction to Laser Physics Safety, Tissue Interaction, & FDA Claims and Labeling Michael M. Barbour MicroLight Corporation of America Founder

Question & AnswersQuestion & Answers