Cleared Traditional

K920795 - 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX

K920795 is an FDA 510(k) clearance for 0R 160, manufactured by Optical Radiation Corp.. The device is a Class 1 Ophthalmic device with product code HQG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K920795

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.

HQG Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQG Lens, Spectacle, Non-custom (prescription)

All 8
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K920795.
FORMALENS 2000
K863367 · Vision-Sciences, Inc. · Sep 1986
SPECTACLES LENS
K860955 · Roseburg SA · Mar 1986
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp. · Oct 1979