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Fda

AkkoLens has taken its first steps towards the US market. In July 2024, a Pre Submission Application was filed with the FDA, followed by a Pre Submission Meeting in September 2024. Based on the FDA's guidance, AkkoLens is working towards Investigational Device Exemption (IDE) approval ,the prerequisite for conducting the multicentre clinical trials required for full FDA registration of the Lumina.

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Other updates

Etz
July 2026

ETZ Tilburg adopts Lumina as a standard premium lens option

Img3
June 2026

Lumina resolves neuro-adaptation failure

Medipolis logo
May 2026

Eye centre Medipolis Antwerp begins commercial implantations

Technopia
April 2026

Technopia Co. Ltd. appointed exclusive distributor for Japan

Funding round
March 2026

AkkoLens closes EUR 6.3 million funding round

Arfamex
February 2026

Arfamex appointed exclusive distributor for Mexico

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