Cleared Traditional

KOWA nonmyd 8

K191945 · Kowa Company , Ltd. · Ophthalmic

Sep 2019

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K191945 is an FDA 510(k) clearance for the KOWA nonmyd 8, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Kowa Company , Ltd. (Chofu-Shi, JP). The FDA issued a Cleared decision on September 10, 2019, 50 days after receiving the submission on July 22, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K191945 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2019
Decision Date	September 10, 2019
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF