Cleared Traditional

OFTALMOGRAF (K833024) - FDA 510(k) Clearance

K833024 · Universal Instruments Corp. · Ophthalmic device
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Apr 1984
Decision
233d
Days
-
Risk

K833024 is an FDA 510(k) clearance for the OFTALMOGRAF.

Submitted by Universal Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1984 after a review of 233 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. 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.

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Submission Details

510(k) Number K833024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date April 26, 1984
Days to Decision 233 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 110d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -