Cleared Traditional

K861643 - STYLEKEEPER CONTACT LENS CARRYING CASE (FDA 510(k) Clearance)

K861643 · Allergan, Inc. · Ophthalmic device
Jun 1986
Decision
33d
Days
-
Risk

K861643 is an FDA 510(k) clearance for the STYLEKEEPER CONTACT LENS CARRYING CASE. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on June 2, 1986, 33 days after receiving the submission on April 30, 1986.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K861643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date June 02, 1986
Days to Decision 33 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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