Cleared Traditional

K833538 - DOWING OPHTHALMIC CHAIR-NON/AC POWER

K833538 is an FDA 510(k) clearance for DOWING OPHTHALMIC CHAIR-NON/AC POWER, manufactured by Vision Health Technology. The device is a Class 1 Ophthalmic device with product code HMD cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K833538 · Vision Health Technology · Ophthalmic device
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Mar 1984
Decision
152d
Days
Class 1
Risk

K833538 is an FDA 510(k) clearance for the DOWING OPHTHALMIC CHAIR-NON/AC POWER. Classified as Chair, Ophthalmic, Manual (product code HMD), 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

FDA 510(k) Submission Details - K833538

510(k) Number K833538 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.

HMD Device Classification - Class 1, General Controls

Product Code HMD Chair, Ophthalmic, Manual
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.