Update on KARL STORZ’s Citizen Petition

Oslo, March 28, 2026 – The U.S. Food and Drug Administration (FDA) has elected to maintain, for the time being, the current regulatory classification for OAY equipment. The petition sought reclassification of diagnostic endoscopic light source systems (FDA Product Code OAY) from Class III to Class II under Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

In its response, the FDA provided important regulatory clarity, outlining, while reclassification was not granted at this time, the requirements necessary to move forward successfully. Specifically, the FDA indicated that additional clinical evidence and more robust, comprehensive special controls are necessary to establish reasonable assurance of safety and effectiveness under a Class II framework. Notably, the Agency did not identify concerns with the underlying technology itself.

Photocure views the FDA’s response as constructive and ultimately positive. While we would have welcomed reclassification at this stage, the FDA’s decision establishes a clear and actionable roadmap for future progress. The Agency’s detailed feedback provides valuable guidance on the clinical and regulatory expectations needed to support a successful reclassification effort.

Importantly, maintaining the current classification does not close the door on future change. New or improved Citizen Petitions may be submitted with enhanced clinical and regulatory support, and the FDA retains the authority to initiate reclassification on its own initiative. The FDA’s feedback meaningfully advances the dialogue toward modernization of the regulatory framework for a mature technology supported by more than a decade of real‑world clinical use.

In addition, the FDA’s decision does not restrict access to the U.S. market. Photocure remains actively engaged with, and is supporting, multiple device manufacturers pursuing established alternative regulatory pathways. We remain confident that these pathways continue to enable innovation, competition, and patient access while aligning with regulatory expectations.

For more information, please contact:

Dan Schneider
President and CEO
Photocure ASA 
Email: mailto: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

Media and IR enquiries: 

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no