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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.](https://reader036.fdocuments.in/reader036/viewer/2022062715/56649d895503460f94a6f4e4/html5/thumbnails/1.jpg)
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.](https://reader036.fdocuments.in/reader036/viewer/2022062715/56649d895503460f94a6f4e4/html5/thumbnails/2.jpg)
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
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HISTORYHISTORY
EinsteinEinstein
Bell LabsBell Labs
MesterMester
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TERMINOLOGYTERMINOLOGY
NanometersNanometers
MilliwattsMilliwatts
PhotonsPhotons
JoulesJoules
Super PulseSuper Pulse
Continuous Continuous WaveWave
DiodeDiode
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ELECTROMAGNETIC SPECTRUMELECTROMAGNETIC SPECTRUM
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LASERSLASERS
MonochromaticMonochromatic
CoherentCoherent
CollimatedCollimated
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SunlightSunlight
LEDLED (light emitting diode)(light emitting diode)
830Laser Produces 830Laser Produces
a Unique Lighta Unique Light MonochromaticMonochromatic CoherentCoherent CollumatedCollumated
WAVEFORMSWAVEFORMS
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LASER TISSUE ABSORPTIONLASER TISSUE ABSORPTION
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Inflammation ReductionInflammation Reduction
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Pain ReductionPain Reduction
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Reduced Healing TimeReduced Healing Time
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LASER CLASSIFICATIONSLASER CLASSIFICATIONS
Class IIIaClass IIIa
Class IIIbClass IIIb
Class IVClass IV
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Class III aClass III a
635 nm635 nm5 mw 5 mw Under FDA Under FDA ReviewReview
ERCHONIAERCHONIA
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Class III bClass III b
830 nm830 nm
90 mw90 mw
Patented Patented
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Class IV Class IV
1 watt of energy1 watt of energy
Cut, vaporize, or coagulateCut, vaporize, or coagulate
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Class III aClass III a
Bar CodeBar Code
Laser PointerLaser Pointer
MedicalMedical
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Class III bClass III b
MilitaryMilitary
ConsumerConsumer
MedicalMedical
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Class IVClass IV
LasikLasik
Hair RemovalHair Removal
WrinklesWrinkles
Brain StrokesBrain Strokes
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L.E.D.’sL.E.D.’s
NanometersNanometers
MilliwattsMilliwatts
Heats TissueHeats Tissue
Not a LaserNot a Laser
880 nm880 nm
500 mw500 mw
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Sports MedicineSports Medicine
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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
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FDA letterheadFDA letterhead
ILY-Infrared Heating LampILY-Infrared Heating LampNHN-Non Heating Infrared LampNHN-Non Heating Infrared LampFDA Warning LetterFDA Warning Letter
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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.
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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.
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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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Visit us at:Visit us at:www.ml830.comwww.ml830.com
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Question & AnswersQuestion & Answers