FDA cleared means the product has an FDA 510(k) document, which is a premarket notiļ¬cation required for
any entity that wants to market a Class I, II, or III device intended for human use in the USA. GameDay is
OTC (over-the-counter) cleared by the FDA, which means it can be used at home without a doctor's
prescription.
FDA Cleared Indications for GameDay Laser:
In the United States, the GameDay Laser is cleared for use at home by the Food and Drug Administration (FDA)
for the following indications:
- Temporary relief of minor muscle and joint pain
- Promoting relaxation of muscle tissue
- Relieving stiffness
- Temporary increase in local blood circulation
- Muscle Spasm
- Arthritis