Cleared Traditional

OTE MPS 045 Multi-purpose Lens Care Solution

K210051 · Ote North America, LLC · Ophthalmic

May 2021

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K210051 is an FDA 510(k) clearance for the OTE MPS 045 Multi-purpose Lens Care Solution, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Ote North America, LLC (Inwood, US). The FDA issued a Cleared decision on May 26, 2021, 138 days after receiving the submission on January 8, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K210051 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2021
Decision Date	May 26, 2021
Days to Decision	138 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF