Cleared Traditional

SPECTACLE FRAMES (K934570) - FDA 510(k) Clearance

Class I Ophthalmic device.

K934570 · Chaser Optical Corp. · Ophthalmic device
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Mar 1994
Decision
166d
Days
Class 1
Risk

K934570 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Chaser Optical Corp. (Kawanishi-Shi, Hyogo-Ken, JP). The FDA issued a Cleared decision on March 1, 1994 after a review of 166 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 Chaser Optical Corp. devices

Submission Details

510(k) Number K934570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1993
Decision Date March 01, 1994
Days to Decision 166 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
56d slower than avg
Panel avg: 110d · This submission: 166d
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.