Cleared Traditional

OCULOSTAT (K981235) - FDA 510(k) Clearance

Class I Ophthalmic device.

K981235 · Laser Center Dev. Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
103d
Days
Class 1
Risk

K981235 is an FDA 510(k) clearance for the OCULOSTAT. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by Laser Center Dev. Corp. (St. Louis, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 K981235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date July 15, 1998
Days to Decision 103 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
7d faster than avg
Panel avg: 110d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNC Specula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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.