Cleared Traditional

HARD CONTACT LENS CLEANING & SOAKING SOLUTION (K853808) - FDA 510(k) Clearance

K853808 · Maurry Biological Co. · Ophthalmic device
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Mar 1986
Decision
181d
Days
-
Risk

K853808 is an FDA 510(k) clearance for the HARD CONTACT LENS CLEANING & 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 March 11, 1986 after a review of 181 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.

View all Maurry Biological Co. devices

Submission Details

510(k) Number K853808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date March 11, 1986
Days to Decision 181 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 110d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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