Cleared Traditional

IN A WINK LUBRICATING & REWETTING DROPS (K853445) - FDA 510(k) Clearance

K853445 · Ciba Vision Care · Ophthalmic device
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Nov 1985
Decision
105d
Days
-
Risk

K853445 is an FDA 510(k) clearance for the IN A WINK LUBRICATING & REWETTING DROPS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Ciba Vision Care (Atlanta, US). The FDA issued a Cleared decision on November 29, 1985 after a review of 105 days - within the typical 510(k) review window.

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 K853445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date November 29, 1985
Days to Decision 105 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 110d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -