Cleared Traditional

HARD CONTACT LENS SOAKING SOLUTION (K853811) - FDA 510(k) Clearance

K853811 · Maurry Biological Co. · Ophthalmic device
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Dec 1985
Decision
96d
Days
-
Risk

K853811 is an FDA 510(k) clearance for the HARD CONTACT LENS SOAKING SOLUTION. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Maurry Biological Co. (Los Angeles, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 96 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 K853811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date December 16, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 110d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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