Cleared Traditional

FRAME, SPECTACLE (K873965) - FDA 510(k) Clearance

Class I Ophthalmic device.

K873965 · Swank Plus , Ltd. · Ophthalmic device
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Apr 1988
Decision
185d
Days
Class 1
Risk

K873965 is an FDA 510(k) clearance for the FRAME, SPECTACLE. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Swank Plus , Ltd. (Hong Kong, HK). The FDA issued a Cleared decision on April 1, 1988 after a review of 185 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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 Swank Plus , Ltd. devices

Submission Details

510(k) Number K873965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1987
Decision Date April 01, 1988
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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.