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FDA 510(k)

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES

K-Number: K972590 · 1997-07-31

ApplicantLbi U.S.A.
Decision Date1997-07-31
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Lbi U.S.A.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K972590. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES?

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Lbi U.S.A.. The 510(k) number is K972590.

When did NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES receive FDA 510(k) clearance?

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES received FDA 510(k) clearance on 1997-07-31, under 510(k) number K972590.

Who is the listed applicant for NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES?

The FDA 510(k) record lists Lbi U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES?

The FDA product code for NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES is HQY.

Related Clinical Trials

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.

Related Devices (Code: HQY)

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.

Official Source

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