Cleared Traditional

ULTRAVUE BLENDED BIFOCAL LENS

K791721 · American Optical Corp. · Ophthalmic
Oct 1979
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K791721 is an FDA 510(k) clearance for the ULTRAVUE BLENDED BIFOCAL LENS, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1979, 54 days after receiving the submission on August 30, 1979. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number K791721 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1979
Decision Date October 23, 1979
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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