FDA applicant

Photocure Asa

Oslo1 decision2004–20040 recalls

FDA records 1 decision for Photocure Asa (Oslo) in 2004: 1 original PMA approval. All are in product code MYH (System, Non-Coherent Light, Photodynamic Therapy). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Photocure Asa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Photocure Asa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Photocure Asa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Photocure Asa

Which product codes does it file in?

What has FDA decided for it lately?