Avulux received De Novo classification from the FDA under DEN250026 on August 21st 2026.
Published
Signal category
Legal & Regulatory
Quote
“FDA granted De Novo classification to Avulux under DEN250026 on August 21st 2026.”
— Avulux team
Company
Avulux
Clinically Proven Migraine & Light Sensitivity Lenses. Now In a Full Portfolio: Avulux, Avulux Adapt, and Avulux Atlas.
- Industry
- Medical Equipment Manufacturing
- Location
- Miami, US
- Company size
- 21 employees
Nearly 2 of every 10 patients an optometrist sees each day is living with a debilitating disorder called migraine. Even more are living with light sensitivity. Avulux is the maker of the first and only FDA De Novo authorized precision optical filter, indicated to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years and older. The leader in light management lenses for people living with migraine and light sensitivity, Avulux offers a portfolio of clinically proven lenses that manage light across indoor, outdoor, and changing light environments. Avulux lenses are worn like ordinary eyeglasses and can be made with or without a wearer’s vision prescription. Authorized for over-the-counter use, Avulux is available without a prescription through eye care providers, optical practices, and authorized partners.
Founded 2019