Cleared Traditional

K853359 - RELIANCE 1379 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K853359 · Dentsply Intl. · Ophthalmic device
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Sep 1985
Decision
43d
Days
Class 1
Risk

K853359 is an FDA 510(k) clearance for the RELIANCE 1379. Classified as Table, Instrument, Powered, Ophthalmic (product code HRJ), Class I - General Controls.

Submitted by Dentsply Intl. (Cincinnati, US). The FDA issued a Cleared decision on September 24, 1985 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4855 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K853359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 24, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 110d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRJ Table, Instrument, Powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4855
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.