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FDA 510(k)

OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004

K-Number: K040664 · 2004-05-28

ApplicantOmnilight, Inc.
Decision Date2004-05-28
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 is the device name listed in this FDA 510(k) record. The listed applicant is Omnilight, Inc.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K040664. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004?

OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Omnilight, Inc.. The 510(k) number is K040664.

When did OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 receive FDA 510(k) clearance?

OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040664.

Who is the listed applicant for OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004?

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

What is the FDA product code for OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004?

The FDA product code for OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 is ILY.

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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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