Cleared Traditional

SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES (K914473) - FDA 510(k) Clearance

Class I Ophthalmic device.

K914473 · Biomedical Optics Co. of America, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
302d
Days
Class 1
Risk

K914473 is an FDA 510(k) clearance for the SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Biomedical Optics Co. of America, Inc. (N. Hollywood, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedical Optics Co. of America, Inc. devices

Submission Details

510(k) Number K914473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date August 05, 1992
Days to Decision 302 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 110d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.