Cleared Traditional

MaxiTears Contacts PF

K182984 · Omnivision AG · Ophthalmic

Jul 2019

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K182984 is an FDA 510(k) clearance for the MaxiTears Contacts PF, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Omnivision AG (Neuhausen Am Rheinfall, CH). The FDA issued a Cleared decision on July 24, 2019, 268 days after receiving the submission on October 29, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number	K182984 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2018
Decision Date	July 24, 2019
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF