Cleared Traditional

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

K920795 · Optical Radiation Corp. · Ophthalmic

Jul 1992

Decision

143d

Days

Class 1

Risk

About This 510(k) Submission

K920795 is an FDA 510(k) clearance for the 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by Optical Radiation Corp. (Azusa, US). The FDA issued a Cleared decision on July 13, 1992, 143 days after receiving the submission on February 21, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number	K920795 FDA.gov
FDA Decision	Cleared 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