Cleared Traditional

K834354 - OPHTEC RUST RING REMOVER

K834354 is an FDA 510(k) clearance for OPHTEC RUST RING REMOVER, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ophthalmic device with product code HOG cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K834354

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

HOG Device Classification - Class 1, General Controls

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.