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FDA 510(k)

VIZILITE EYEWEAR

K-Number: K080043 · 2008-04-04

ApplicantZila, Inc.
Decision Date2008-04-04
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIZILITE EYEWEAR is the device name listed in this FDA 510(k) record. The listed applicant is Zila, Inc.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080043. The device is classified under product code NXV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIZILITE EYEWEAR?

VIZILITE EYEWEAR is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Zila, Inc.. The 510(k) number is K080043.

When did VIZILITE EYEWEAR receive FDA 510(k) clearance?

VIZILITE EYEWEAR received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080043.

Who is the listed applicant for VIZILITE EYEWEAR?

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

What is the FDA product code for VIZILITE EYEWEAR?

The FDA product code for VIZILITE EYEWEAR is NXV.

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Related Devices (Code: NXV)

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Official Source

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

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