Cleared Traditional

DOWNING SPECTRAL ILLUMINATOR (K833446) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833446 · Vision Health Technology · Ophthalmic device
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Mar 1984
Decision
159d
Days
Class 2
Risk

K833446 is an FDA 510(k) clearance for the DOWNING SPECTRAL ILLUMINATOR. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Vision Health Technology (Walker, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 159 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - 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 Vision Health Technology devices

Submission Details

510(k) Number K833446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date March 12, 1984
Days to Decision 159 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 slower than avg
Panel avg: 110d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.