Cleared Traditional

LENSKEEPER CONTACT LENS CARRYING CASE (K861642) - FDA 510(k) Clearance

K861642 · Allergan, Inc. · Ophthalmic device
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May 1986
Decision
29d
Days
-
Risk

K861642 is an FDA 510(k) clearance for the LENSKEEPER CONTACT LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 29 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, Inc. devices

Submission Details

510(k) Number K861642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date May 29, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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