Cleared Traditional

MOSSIMO OPTIC EYEWEAR (K912509) - FDA 510(k) Clearance

Class I Ophthalmic device.

K912509 · Mossimo, Inc. · Ophthalmic device
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Jan 1992
Decision
214d
Days
Class 1
Risk

K912509 is an FDA 510(k) clearance for the MOSSIMO OPTIC EYEWEAR. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Mossimo, Inc. (Irvine, US). The FDA issued a Cleared decision on January 6, 1992 after a review of 214 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 Mossimo, Inc. devices

Submission Details

510(k) Number K912509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date January 06, 1992
Days to Decision 214 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
104d slower than avg
Panel avg: 110d · This submission: 214d
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.