Cleared Traditional

NON-PRESCRIPTION SUNGLASSES (K941267) - FDA 510(k) Clearance

Class I Ophthalmic device.

K941267 · Topstar Trading , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
338d
Days
Class 1
Risk

K941267 is an FDA 510(k) clearance for the NON-PRESCRIPTION SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Topstar Trading , Ltd. (Kowloon Hong Kong, HK). The FDA issued a Cleared decision on February 17, 1995 after a review of 338 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 Topstar Trading , Ltd. devices

Submission Details

510(k) Number K941267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1994
Decision Date February 17, 1995
Days to Decision 338 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
228d slower than avg
Panel avg: 110d · This submission: 338d
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.