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FDA 510(k)

VISULAS yag

K-Number: K230350 · 2023-09-22

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2023-09-22
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISULAS yag is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K230350. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISULAS yag?

VISULAS yag is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K230350.

When did VISULAS yag receive FDA 510(k) clearance?

VISULAS yag received FDA 510(k) clearance on 2023-09-22, under 510(k) number K230350.

Who is the listed applicant for VISULAS yag?

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

What is the FDA product code for VISULAS yag?

The FDA product code for VISULAS yag is HQF.

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Other records listing Carl Zeiss Meditec, Inc. as applicant

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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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