Cleared Traditional

PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE (K850046) - FDA 510(k) Clearance

K850046 · Professional Supplies, Inc. · Ophthalmic device
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Apr 1985
Decision
98d
Days
-
Risk

K850046 is an FDA 510(k) clearance for the PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Professional Supplies, Inc. (Stevens Point, US). The FDA issued a Cleared decision on April 15, 1985 after a review of 98 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.

View all Professional Supplies, Inc. devices

Submission Details

510(k) Number K850046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date April 15, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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