The FDA has granted De Novo marketing authorisation to Avulux, establishing a new medical device classification for a lens designed to reduce light sensitivity associated with episodic migraine.

FDA creates new device classification

The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Avulux, a precision optical filter designed to reduce the impact of light sensitivity in people with episodic migraine.

The FDA’s De Novo database records the decision for Avulux under De Novo number DEN250026, with the decision granted on August 21, 2026. The device was reviewed by the agency’s neurology advisory committee.

The De Novo pathway is used for certain new medical devices for which there is no legally marketed predicate device against which to establish substantial equivalence. The decision establishes a regulatory classification for the Avulux device.

Avulux is indicated for people aged 12 years and older with episodic migraine. The optical filter is designed to block light at 480 nm and 590 nm while allowing other visible wavelengths to pass through.

The device is worn as a pair of glasses and can be supplied with or without prescription vision correction. The company states that its use is intended to complement, rather than replace, usual migraine treatment, including medication.

Light sensitivity is common in migraine

Light sensitivity, or photophobia, is a common symptom of migraine and can contribute to pain and disruption to daily activities.

The company says up to 90% of people with migraine experience light sensitivity, while some migraine attacks can also be triggered or worsened by exposure to light.

The Avulux filter is designed around research suggesting that particular wavelengths can have different effects on people experiencing migraine. By selectively filtering specific wavelengths while allowing other visible light through, the device is intended to reduce the impact of light sensitivity.

The FDA authorisation follows the agency’s review of clinical evidence submitted by the company, including randomised controlled trials and other clinical data.

Charles Posternack, co-founder and chief executive officer of Avulux, said: “For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed.”

He added: “This authorization gives patients and providers a clear, FDA-recognized option designed specifically to manage the impact of light in those with migraine, one we hope will soon become the standard of medical care in this population.”

Device expands migraine management options

The authorisation applies to patients diagnosed with episodic migraine aged 12 and older and addresses light sensitivity rather than migraine itself.

The distinction is important because the device is not intended to replace established migraine therapies. Patients using Avulux should continue their prescribed treatment, including medication.

The company said the device has previously been dispensed to more than 50,000 users and is available through participating eye care providers and optical practices. These figures describe the company’s existing use of the product and are separate from the FDA’s regulatory decision.

The De Novo authorisation creates a recognised regulatory pathway for the device type and could also provide a basis for future devices with similar characteristics to be assessed under the new classification.

For migraine patients, the decision adds a regulated medical device specifically intended to address light sensitivity, a symptom that can be particularly disruptive during attacks.