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FDA 510(k)

VISULUX

K-Number: K161607 · 2017-02-23

ApplicantCarl Zeiss Meditec, AG
Decision Date2017-02-23
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISULUX 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 2017-02-23 under 510(k) number K161607. 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 VISULUX?

VISULUX is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K161607.

When did VISULUX receive FDA 510(k) clearance?

VISULUX received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161607.

Who is the listed applicant for VISULUX?

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 VISULUX?

The FDA product code for VISULUX is HJO.

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Other records listing Carl Zeiss Meditec, AG as applicant

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Related Devices (Code: HJO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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