Cleared Traditional

DOWING OPHTHALMIC CHAIR AC-POWERED (K833539) - FDA 510(k) Clearance

Class I Ophthalmic device.

K833539 · Vision Health Technology · Ophthalmic device
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Mar 1984
Decision
152d
Days
Class 1
Risk

K833539 is an FDA 510(k) clearance for the DOWING OPHTHALMIC CHAIR AC-POWERED. Classified as Chair, Ophthalmic, Ac-powered (product code HME), Class I - General Controls.

Submitted by Vision Health Technology (Walker, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 152 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1140 - 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 K833539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date March 05, 1984
Days to Decision 152 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 110d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HME Chair, Ophthalmic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1140
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.