Cleared Traditional

K900877 - OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION

K900877 is an FDA 510(k) clearance for OPTHALMIC QUALITY SUNGLASSES, manufactured by Sunglass Originals, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K900877 · Sunglass Originals, Inc. · Ophthalmic device
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Jul 1990
Decision
151d
Days
Class 1
Risk

K900877 is an FDA 510(k) clearance for the OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Sunglass Originals, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 151 days - an extended review cycle.

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 Sunglass Originals, Inc. devices

FDA 510(k) Submission Details - K900877

510(k) Number K900877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1990
Decision Date July 27, 1990
Days to Decision 151 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 110d · This submission: 151d
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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K900877.
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