Cleared Traditional

K981235 - OCULOSTAT

K981235 is an FDA 510(k) clearance for OCULOSTAT, manufactured by Laser Center Dev. Corp.. The device is a Class 1 Ophthalmic device with product code HNC cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K981235

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 110d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

HNC Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNC Specula, Ophthalmic

All 7
Devices cleared under the same product code (HNC) and FDA review panel - the closest regulatory comparables to K981235.
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