Cleared Traditional

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

Class I Ophthalmic device.

K981063 · Laser Center Dev. Corp. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
92d
Days
Class 1
Risk

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

Submitted by Laser Center Dev. Corp. (St. Louis, US). The FDA issued a Cleared decision on June 23, 1998 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Laser Center Dev. Corp. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.