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

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

HISTORY Einstein Einstein Bell Labs Bell Labs Mester Mester

TERMINOLOGY NanometersMilliwatts Photons Photons Joules Joules Super Pulse Continuous Wave Diode

ELECTROMAGNETIC SPECTRUM

LASERS Monochromatic Monochromatic Coherent Coherent Collimated Collimated

Sunlight LED (light emitting diode) 830Laser Produces a Unique Light a Unique Light Monochromatic Monochromatic Coherent Coherent Collumated CollumatedWAVEFORMS

LASER TISSUE ABSORPTION

Inflammation Reduction

Pain Reduction

Reduced Healing Time

LASER CLASSIFICATIONS Class IIIa Class IIIa Class IIIb Class IIIb Class IV Class IV

Class III a 635 nm 5 mw Under FDA Review ERCHONIA

Class III b 830 nm 830 nm 90 mw 90 mw Patented Patented

Class IV 1 watt of energy 1 watt of energy Cut, vaporize, or coagulate

Class III a Bar Code Laser Pointer Medical

Class III b MilitaryConsumerMedical

Class IV Lasik Hair Removal Wrinkles Brain Strokes

L.E.D.’s Nanometers Nanometers Milliwatts Milliwatts Heats Tissue Heats Tissue Not a Laser Not a Laser 880 nm 500 mw

Sports Medicine

ML830 Laser Direct Connect Laser 830nm probe 830nm probe A/C cord A/C cord Laser Glasses Laser Glasses Case Case Portable Battery Laser 830nm Probe 830nm Probe 3 lithium batteries 3 lithium batteries Charger and power meter Charger and power meter Laser Glasses Laser Glasses Cases Cases

FDA letterhead ILY-Infrared Heating Lamp NHN-Non Heating Infrared Lamp FDA Warning Letter

Studies Treatment of repetitive use carpal tunnel syndrome Smith CF, Vangsness CT, Anderson T & Good W (1995) Proceedings SPINE (1995) 2395; Noninvasive laser neurolysis in carpal tunnel syndrome Weintraub MI, MD, FACP Muscle Nerve (1997) 20: 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.

Studies The 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): Low level laser therapy for tendinopathy. Evidence of a dose- response pattern Bjordal J M, Couppe´ C, Ljunggren E Physical Therapy Reviews (2001) 6: 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 HistoryTerminologyLasersL.E.D.’s FDA Claims and Labeling Review of the Literature

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