Cleared Traditional

OMS/GONVERS RETINAL PERFORATOR (K844448) - FDA 510(k) Clearance

Class I Ophthalmic device.

K844448 · Optical Micro Systems, Inc. · Ophthalmic device
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Aug 1985
Decision
278d
Days
Class 1
Risk

K844448 is an FDA 510(k) clearance for the OMS/GONVERS RETINAL PERFORATOR. Classified as Needle, Ophthalmic Suturing (product code HNM), Class I - General Controls.

Submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 278 days - an extended review cycle.

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 Optical Micro Systems, Inc. devices

Submission Details

510(k) Number K844448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date August 21, 1985
Days to Decision 278 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 110d · This submission: 278d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNM Needle, Ophthalmic Suturing
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.