Cleared Traditional

SKIASCOPIC RACKS (K844364) - FDA 510(k) Clearance

Class I Ophthalmic device.

K844364 · Luneau Laboratories · Ophthalmic device
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Jan 1985
Decision
50d
Days
Class 1
Risk

K844364 is an FDA 510(k) clearance for the SKIASCOPIC RACKS. Classified as Rack, Skiascopic (product code HMH), Class I - General Controls.

Submitted by Luneau Laboratories (Walker, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1750 - 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 Luneau Laboratories devices

Submission Details

510(k) Number K844364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 02, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMH Rack, Skiascopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1750
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.