FDA 510(k)

CVUE ADVANCED HYDRA VUE

K-Number: K121652 · 2012-10-05

Decision Date2012-10-05

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CVUE ADVANCED HYDRA VUE is the device name listed in this FDA 510(k) record. The listed applicant is Unilens Corp., USA. It received FDA 510(k) clearance on 2012-10-05 under 510(k) number K121652. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVUE ADVANCED HYDRA VUE?

CVUE ADVANCED HYDRA VUE is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Unilens Corp., USA. The 510(k) number is K121652.

When did CVUE ADVANCED HYDRA VUE receive FDA 510(k) clearance?

CVUE ADVANCED HYDRA VUE received FDA 510(k) clearance on 2012-10-05, under 510(k) number K121652.

Who is the listed applicant for CVUE ADVANCED HYDRA VUE?

The FDA 510(k) record lists Unilens Corp., USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CVUE ADVANCED HYDRA VUE?

The FDA product code for CVUE ADVANCED HYDRA VUE is LPL.

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Other records listing Unilens Corp., USA 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.