Cleared Traditional

K981063 - AUTOMATED CORNEAL TREPHINE
(FDA 510(k) Clearance)

K981063 · Laser Center Dev. Corp. · Ophthalmic device

Jun 1998

Decision

92d

Days

Class 1

Risk

K981063 is an FDA 510(k) clearance for the AUTOMATED CORNEAL TREPHINE. This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I - General Controls, product code HRG).

Submitted by Laser Center Dev. Corp. (St. Louis, US). The FDA issued a Cleared decision on June 23, 1998, 92 days after receiving the submission on March 23, 1998.

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

Submission Details

510(k) Number	K981063 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 23, 1998
Decision Date	June 23, 1998
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF