Cleared Traditional

K190674 - REFRESH RELIEVA For CONTACTS
(FDA 510(k) Clearance)

K190674 · Allergan, Inc. · Ophthalmic

Aug 2019

Decision

146d

Days

Class 2

Risk

K190674 is an FDA 510(k) clearance for the REFRESH RELIEVA For CONTACTS, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on August 8, 2019, 146 days after receiving the submission on March 15, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K190674 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2019
Decision Date	August 08, 2019
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF