Cleared Traditional

SILA CLEAN 20/20 (K832327) - FDA 510(k) Clearance

K832327 · Professional Supplies, Inc. · Ophthalmic device
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Jul 1984
Decision
360d
Days
-
Risk

K832327 is an FDA 510(k) clearance for the SILA CLEAN 20/20.

Submitted by Professional Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on July 9, 1984 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K832327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1983
Decision Date July 09, 1984
Days to Decision 360 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 110d · This submission: 360d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -