Cleared Traditional

LENSKEEPER LENS CARRYING CASE (K843342) - FDA 510(k) Clearance

K843342 · Allergan Pharmaceuticals, Inc. · Ophthalmic device
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Nov 1984
Decision
84d
Days
-
Risk

K843342 is an FDA 510(k) clearance for the LENSKEEPER LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan Pharmaceuticals, Inc. (Irvine, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allergan Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K843342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date November 19, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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