Cleared Traditional

K083812 - REFRESH OPTIVE LENS COMFORT REWETTING DROPS
(FDA 510(k) Clearance)

K083812 · Allergan, Inc. · Ophthalmic

Jul 2009

Decision

199d

Days

Class 2

Risk

K083812 is an FDA 510(k) clearance for the REFRESH OPTIVE LENS COMFORT REWETTING DROPS. This device is classified as a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN).

Submitted by Allergan, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 9, 2009, 199 days after receiving the submission on December 22, 2008.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K083812 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2008
Decision Date	July 09, 2009
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF