Cleared Traditional

Myopia Master

K202989 · Oculus Optikger?te GmbH · Ophthalmic

Jul 2021

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K202989 is an FDA 510(k) clearance for the Myopia Master, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Oculus Optikger?te GmbH (Wetzlar, DE). The FDA issued a Cleared decision on July 14, 2021, 287 days after receiving the submission on September 30, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K202989 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2020
Decision Date	July 14, 2021
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF