Photocure ASA: Update on Regulatory Classification for OAY Equipment

OSLO, Norway, April 13, 2026 /PRNewswire/ — Photocure ASA (OSE: PHO) today announced that the U.S. Food and Drug Administration (FDA) has communicated to Photocure that it plans to issue a proposed order to reclassify diagnostic endoscopic light source systems (FDA Product Code OAY) under its own initiative per Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

This information was shared with Photocure as part of its ongoing dialogue with the FDA, following the Reclassification Petition submitted by Karl Storz SE & Co. KG and addressed in Photocure’s press release of 28 March 2026. Consistent with FDA’s response to the Reclassification Petition, which did not preclude the agency from reclassifying on its own initiative, and subject to internal processes, FDA intends on issuing a proposed order to reclassify FDA Product Code OAY in the second half of 2026. Any potential reclassification will proceed through the FDA’s established processes, with final determinations made by the agency.

For further information, please contact: 
Dan Schneider
President and CEO
Photocure ASA 
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA 
Tel: +47 45055000
Email: ed@photocure.com

Priyam Shah
Vice President Investor Relations
Tel: +17176815072
Email: priyam.shah@photocure.com