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FDA 510(k)

VISUREF 600

K-Number: K253834 · 2026-03-18

ApplicantCarl Zeiss Vision GmbH
Decision Date2026-03-18
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISUREF 600 is a medical device manufactured by Carl Zeiss Vision GmbH. It received FDA 510(k) clearance on 2026-03-18 under approval number K253834. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUREF 600?

VISUREF 600 is a medical device that received FDA 510(k) clearance on 2026-03-18. It is manufactured by Carl Zeiss Vision GmbH. The 510(k) number is K253834.

When was VISUREF 600 approved by the FDA?

VISUREF 600 received FDA 510(k) clearance on 2026-03-18, under approval number K253834.

What company makes VISUREF 600?

VISUREF 600 is manufactured by Carl Zeiss Vision GmbH.

What is the FDA product code for VISUREF 600?

The FDA product code for VISUREF 600 is HJO.

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Official Source

View on FDA Database →

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