Cleared Traditional

(MICRO-KERATRON, MICRO DUCT TREPHINE) (K791763) - FDA 510(k) Clearance

Class I Ophthalmic device.

K791763 · Intl. Ophthalmic Industries Corp. · Ophthalmic device
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Nov 1979
Decision
61d
Days
Class 1
Risk

K791763 is an FDA 510(k) clearance for the (MICRO-KERATRON, MICRO DUCT TREPHINE). Classified as Engine, Trephine, Accessories, Ac-powered (product code HRG), Class I - General Controls.

Submitted by Intl. Ophthalmic Industries Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 61 days - a notably fast clearance cycle.

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: 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 Intl. Ophthalmic Industries Corp. devices

Submission Details

510(k) Number K791763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1979
Decision Date November 05, 1979
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 110d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-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.