Cleared Traditional

OMS QUARTZ INFUSION CONTACT LENS

K820223 · Optical Micro Systems, Inc. · Ophthalmic
Feb 1982
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K820223 is an FDA 510(k) clearance for the OMS QUARTZ INFUSION CONTACT LENS, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982, 9 days after receiving the submission on January 27, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number K820223 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1982
Decision Date February 05, 1982
Days to Decision 9 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJI — Lens, Fundus, Hruby, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1395