Cleared Traditional

K981063 - AUTOMATED CORNEAL TREPHINE

K981063 is an FDA 510(k) clearance for AUTOMATED CORNEAL TREPHINE, manufactured by Laser Center Dev. Corp.. The device is a Class 1 Ophthalmic device with product code HRG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K981063 · Laser Center Dev. Corp. · Ophthalmic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K981063

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

HRG Device Classification - Class 1, General Controls

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.