Cleared Traditional

HARD CONTACT LENS CASE (K831973) - FDA 510(k) Clearance

K831973 · Moonbeam International, Inc. · Ophthalmic device
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Oct 1983
Decision
121d
Days
-
Risk

K831973 is an FDA 510(k) clearance for the HARD CONTACT LENS CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Moonbeam International, Inc. (Walker, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 121 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 Moonbeam International, Inc. devices

Submission Details

510(k) Number K831973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date October 19, 1983
Days to Decision 121 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 110d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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