Cleared Traditional

0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795) - FDA 510(k) Clearance

Class I Ophthalmic device.

K920795 · Optical Radiation Corp. · Ophthalmic device
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Jul 1992
Decision
143d
Days
Class 1
Risk

K920795 is an FDA 510(k) clearance for the 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Optical Radiation Corp. (Azusa, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - 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 Optical Radiation Corp. devices

Submission Details

510(k) Number K920795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1992
Decision Date July 13, 1992
Days to Decision 143 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
33d slower than avg
Panel avg: 110d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
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.