Cleared Traditional

SPECTACLE FRAMES (K941211) - FDA 510(k) Clearance

Class I Ophthalmic device.

K941211 · H & M Optical (U.S.A.) , Ltd. · Ophthalmic device
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Jun 1994
Decision
99d
Days
Class 1
Risk

K941211 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by H & M Optical (U.S.A.) , Ltd. (Ontario, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 99 days - within the typical 510(k) review window.

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 H & M Optical (U.S.A.) , Ltd. devices

Submission Details

510(k) Number K941211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date June 17, 1994
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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.