Indications for Use: Avulux® is an FDA-authorized,
over-the-counter precision optical filter indicated to block light at
480 nm (high blue range) and 590 nm (red/amber range), while
allowing light in the remaining visible color spectrum through, to decrease
the impact of light sensitivity in patients diagnosed with episodic migraine
aged 12 years and older. The use of Avulux should not alter the usual care
therapy of patients diagnosed with episodic migraine, including medication
usage.
Avulux is intended to be used as an adjunct to other therapies for
migraine-associated light sensitivity. It is not intended to diagnose,
treat, cure, or prevent migraine or any other disease and is not a substitute
for professional medical advice, diagnosis, or treatment. Consult a qualified
healthcare professional regarding migraine symptoms and treatment. Avulux is
classified by the U.S. Food and Drug Administration as a Class I medical
device under 21 CFR § 882.5811, product code QEO.
De Novo request DEN250026.
