Cleared Traditional

K935446 - VISUAL HEALTHSHIELDS

K935446 is an FDA 510(k) clearance for VISUAL HEALTHSHIELDS, manufactured by Yorktowne Optical Co., Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K935446 · Yorktowne Optical Co., Inc. · Ophthalmic device
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Feb 1994
Decision
97d
Days
Class 1
Risk

K935446 is an FDA 510(k) clearance for the VISUAL HEALTHSHIELDS. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Yorktowne Optical Co., Inc. (Emigsville, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Yorktowne Optical Co., Inc. devices

FDA 510(k) Submission Details - K935446

510(k) Number K935446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date February 17, 1994
Days to Decision 97 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
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

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.