Cleared Traditional

KOWA DR-1a

K190573 · Kowa Company , Ltd. · Ophthalmic

Jun 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K190573 is an FDA 510(k) clearance for the KOWA DR-1a, 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 June 4, 2019, 90 days after receiving the submission on March 6, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K190573 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2019
Decision Date	June 04, 2019
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF