Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

METALLIC SUNGLASSES

K-Number: K852902 · 1985-08-12

Decision Date1985-08-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

METALLIC SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Yours Enterprise Co., Ltd.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K852902. 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 METALLIC SUNGLASSES?

METALLIC SUNGLASSES is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Yours Enterprise Co., Ltd.. The 510(k) number is K852902.

When did METALLIC SUNGLASSES receive FDA 510(k) clearance?

METALLIC SUNGLASSES received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852902.

Who is the listed applicant for METALLIC SUNGLASSES?

The FDA 510(k) record lists Yours Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METALLIC SUNGLASSES?

The FDA product code for METALLIC 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

View on FDA Database →

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

↑