510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920795Substantially Equivalent

0R 160, or-1.60, and Orcolite 1.60 High Index

Optical Radiation Corp., Azusa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920795 is the FDA 510(k) clearance record for 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX, a class I device, cleared for Optical Radiation Corp. on under FDA product code HQG (Lens, Spectacle, Non-Custom (Prescription)). FDA records list 3 510(k) clearances for Optical Radiation Corp., from to . As of , FDA records show no recalls naming K920795.

Clearance record

Decision date
Received
(143 days to decision)
Product code
HQG Lens, Spectacle, Non-Custom (Prescription)
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Optical Radiation Corp. 1300 Optical Dr., Azusa CA
510(k) summary
Statement
Third party review
No

Clearances, product code HQG

Trailing 12 months

FDA records hold no clearances under product code HQG in the trailing twelve months.

FDA records show no clearances under product code HQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260