Cleared Traditional

K934859 - CONTACT LENSES
(FDA 510(k) Clearance)

K934859 · Arno Intl., Inc. · Ophthalmic device

Dec 1993

Decision

70d

Days

Class 1

Risk

K934859 is an FDA 510(k) clearance for the CONTACT LENSES. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).

Submitted by Arno Intl., Inc. (Plantation, US). The FDA issued a Cleared decision on December 21, 1993, 70 days after receiving the submission on October 12, 1993.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.

Submission Details

510(k) Number	K934859 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 12, 1993
Decision Date	December 21, 1993
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement