Cleared Traditional

K823767 - ERG-JET ELECTRODE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K823767 · Life-Tech Intl., Inc. · Ophthalmic device
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Jan 1983
Decision
25d
Days
Class 1
Risk

K823767 is an FDA 510(k) clearance for the ERG-JET ELECTRODE. Classified as Device, Measuring, Lens Radius, Ophthalmic (product code HLF), Class I - General Controls.

Submitted by Life-Tech Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1430 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K823767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date January 08, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 110d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLF Device, Measuring, Lens Radius, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1430
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.