Did you know that over 44 Cold Lasers have Received FDA Clearance for Human Use Applications in the US?
The use of Cold Lasers and the birth of Cold Laser Therapy (CLT) began in the 1960s by a Hungarian physician named Endre Mester. It was further supported by Albert Einstein, who said, “I will think for the rest of my life about what light is.” Cold laser devices are also known as Low Level Lasers for use in Low Level Laser Therapy (LLLT), which now has a 50+ year track record of success in treating a wide range of symptoms and conditions. They have been very successful and in some cases, totally life transforming for use in musculoskeletal conditions, and made famous in the US in a GM Study for the relief of carpal tunnel syndrome. Helping many people to prevent the need for operations. Cold Laser Therapy is being used successfully to promote natural PAIN RELIEF and to treat fibromyalgia, inflammatory conditions, osteoarthritis, rheumatoid arthritis, wound healing, smoking cessation, weight loss, body contouring, temporomandibular joint (TMJ) disorders, tennis and golfer’s elbow, neck, back, leg, foot, arm, hand and finger pain and much more. The recommended dosage, number of treatments, and length of treatment vary from one device to another, and results vary from person to person. There is a wide range of power output and price differences in the different cold laser therapy devices. More recently there has been a move by practitioners to more powerful Hot Lasers AKA Class IV Lasers, which are considerably more expensive, but work much faster.
In 2002 the first Cold Laser or Low Level Laser received FDA Clearance.
Erchonia manufactured and marketed their cold lasers specifically to the Chiropractic market and price was high at about $12,000 to $16,000. They specialized in pulsed Red diode lasers with low power of 10-20mW. Next came the ML830 Cold Laser, which sported 100mw of Continuous Wave (CW) near Infrared (IR) Laser. The U.S. Food and Drug Administration (FDA) classifies many Cold Laser devices as Class II devices as “lamp, non-heating, for adjunctive use in pain therapy” (product code NHN) and others have an ILY rating. The fact is, no lasers can be sold in the US for use on humans without either receiving an FDA clearance for such, or being in an IRB, which conducts clinical studies on patients in order to get a better understanding of clinical outcomes.
Between 2002 and 2016 44 Cold Laser Devices Received 510(k) Clearance for marketing or Cold Laser Therapy devices for temporary pain relief and other ailments. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.
Here is a Partial List of the 44 Low Level Lasers Marketed in the US:
Acculaser Pro Low Level Laser Therapy Device; Acculaser Pro4; Axiom Biolaser LLLT Series-1; Axiom Biolaser LLLT Series-3; Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System; Collagentex Rx-1; Diobeam 830; Elite Electromed L.I.T.E. 4/1; Erchonia’s Allay, Emerge, EML Laser, EML Laser; Evri, Mis-Ac Derma Scanner, Pl2000, Pi5000, Pi Touch, and TH1 Laser; Excalibur IV Light Therapy System Model SGEX4-001; Excalibur Light Therapy System Model SGLEX-04-001; GRT Lite Model 8-A; Lapex 2000; Laser Helmet, Lasertouchone; Lazrpulsr 4x; Ld-I 75 And LD-I 200; LEP2000 Therapy System; Lightstream Low Level Laser; Luminex LL Laser System; Lx-100 Hair Growth Stimulation System; Medx LCS Laser Series; MRM Multi Radiance Medical Laser Therapy Systems, Microlight 830 Laser System (ML830); NMA 1052 Console System With NMA 100 Laser Accessory; Omega Excel/XP Laser System; Power Laser 90; QLaser System; Quantum Light Therapy System; Scalar Wave Laser Therapy System, Sunetics Clinical Bio-Stimulation Laser; TerraQuant Laser Therapy Systems, Theralase TLC-2000 Therapeutic Medical Laser System; Thor DDII 830CL3 Laser System; Tlc-2000 Therapeutic Medical Laser System; and Trilumina Therapeutic Laser System. Most of the clearances were for symptoms related to wrist pain due to carpal tunnel syndrome, but a few mentioned temporary relief of muscle stiffness, minor arthritis pain, and/or temporary increase in local blood circulation. The FDA has also cleared one device, the LTU-904 Portable Laser Therapy Unit. Several of these companies are no longer in business.