Cleared Traditional

Kowa SL-19

K222372 · Kowa Company , Ltd. · Ophthalmic

Nov 2022

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K222372 is an FDA 510(k) clearance for the Kowa SL-19, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Kowa Company , Ltd. (Chofu-Shi, JP). The FDA issued a Cleared decision on November 21, 2022, 108 days after receiving the submission on August 5, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K222372 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2022
Decision Date	November 21, 2022
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF