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FDA 510(k)

OPTILUX 501

K-Number: K020091 · 2002-03-21

ApplicantKerr Corporation (Danbury)
Decision Date2002-03-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTILUX 501 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 2002-03-21 under 510(k) number K020091. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTILUX 501?

OPTILUX 501 is a medical device that received FDA 510(k) clearance on 2002-03-21. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K020091.

When did OPTILUX 501 receive FDA 510(k) clearance?

OPTILUX 501 received FDA 510(k) clearance on 2002-03-21, under 510(k) number K020091.

Who is the listed applicant for OPTILUX 501?

The FDA 510(k) record lists Kerr Corporation (Danbury) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTILUX 501?

The FDA product code for OPTILUX 501 is EBZ.

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Other records listing Kerr Corporation (Danbury) as applicant

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Related Devices (Code: EBZ)

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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