Cleared Traditional

K834354 - OPHTEC RUST RING REMOVER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K834354 · Jedmed Instrument Co. · Ophthalmic device
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Mar 1984
Decision
97d
Days
Class 1
Risk

K834354 is an FDA 510(k) clearance for the OPHTEC RUST RING REMOVER. Classified as Burr, Corneal, Battery-powered (product code HOG), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 97 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K834354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date March 19, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOG Burr, Corneal, Battery-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.