Cleared Traditional

K831973 - HARD CONTACT LENS CASE

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 -

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 19
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K831973.
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
K830740 · CooperVision, Inc. · Jun 1983
PRE-SERT
K822706 · Allergan, Inc. · Oct 1982