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FDA 510(k)

DUALENZ LOW VISION EYEWEAR

K-Number: K864594 · 1987-01-20

ApplicantGlobal Eye Care, Inc.
Decision Date1987-01-20
Product CodeHKK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DUALENZ LOW VISION EYEWEAR is the device name listed in this FDA 510(k) record. The listed applicant is Global Eye Care, Inc.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K864594. The device is classified under product code HKK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUALENZ LOW VISION EYEWEAR?

DUALENZ LOW VISION EYEWEAR is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Global Eye Care, Inc.. The 510(k) number is K864594.

When did DUALENZ LOW VISION EYEWEAR receive FDA 510(k) clearance?

DUALENZ LOW VISION EYEWEAR received FDA 510(k) clearance on 1987-01-20, under 510(k) number K864594.

Who is the listed applicant for DUALENZ LOW VISION EYEWEAR?

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

What is the FDA product code for DUALENZ LOW VISION EYEWEAR?

The FDA product code for DUALENZ LOW VISION EYEWEAR is HKK.

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Related Devices (Code: HKK)

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

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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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