Cleared Traditional

K843957 - ULTRATHIN/SP LENS
(FDA 510(k) Clearance)

K843957 · Optical Systems Intl., Inc. · Ophthalmic device

Jul 1985

Decision

294d

Days

Class 1

Risk

K843957 is an FDA 510(k) clearance for the ULTRATHIN/SP LENS. This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I - General Controls, product code HRG).

Submitted by Optical Systems Intl., Inc. (Hialeah, US). The FDA issued a Cleared decision on July 31, 1985, 294 days after receiving the submission on October 10, 1984.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.

Submission Details

510(k) Number	K843957 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 10, 1984
Decision Date	July 31, 1985
Days to Decision	294 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—