Is cold laser therapy FDA approved?

The Food and Drug Administration (FDA) recognizes four major classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser.

Three categories among them are classified as medical lasers by FDA. These are Class 3A Non-surgical Lasers, Class 3B Low-Level Lasers, and Class 4 Surgical Lasers.

Class 4 Surgical Lasers are used to cut, coagulate, and vaporize tissue. This is different from Class 3A and Class 3B lasers, which are non-surgical, painless, non-burning, and non-cutting forms of lasers. Class 3A or Class 3B which belong to Low-Level Lasers do not have the intensity to damage cells. Class 3A lasers help heal superficial wounds and conditions and will typically not penetrate below the skin’s surface. However, Class 3B low-level lasers have the ability to penetrate and assist in the healing process of deep tissue and joint problems.

The first experimental FDA clearance of Class 3B Lasers occurred in February of 2002, after a successful study for carpal tunnel syndrome on workers at General Motors.

Cold laser devices are also FDA approved for relief of the following conditions:

  • Muscle and joint pain
  • Stiffness associated with arthritis
  • Pain associated with muscle spasms
  • Hand pain and wrist pain associated with Carpal Tunnel Syndrome
  • Neck pain
  • Lower back pain
  • Wound healing

Is cold laser therapy FDA approved

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