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FDA 510(k)

IOLMASTER 500

K-Number: K122418 · 2013-04-12

ApplicantCarl Zeiss Meditec, AG
Decision Date2013-04-12
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IOLMASTER 500 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2013-04-12 under 510(k) number K122418. 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 IOLMASTER 500?

IOLMASTER 500 is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K122418.

When did IOLMASTER 500 receive FDA 510(k) clearance?

IOLMASTER 500 received FDA 510(k) clearance on 2013-04-12, under 510(k) number K122418.

Who is the listed applicant for IOLMASTER 500?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IOLMASTER 500?

The FDA product code for IOLMASTER 500 is HJO.

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Related Devices (Code: HJO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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