Cleared Traditional

K813313 - BIOMICROSCOPY CONTACT LENS (FDA 510(k) Clearance)

K813313 · Design Research Assoc., Inc. · Ophthalmic device

Mar 1982

Decision

97d

Days

Class 2

Risk

K813313 is an FDA 510(k) clearance for the BIOMICROSCOPY CONTACT LENS. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).

Submitted by Design Research Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982, 97 days after receiving the submission on November 24, 1981.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K813313 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 24, 1981
Decision Date	March 01, 1982
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—