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FDAAvulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity

Avulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity

An FDA-authorized lens for the light sensitivity that affects nearly 9 in 10 people with migraine. Miami, FL – August 24, 2026 – Avulux, the maker of clinically-proven precision light-filtering len...

24 août 2026

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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.