510(k) clearance

KOWA FM-600

FDA 510(k) source

510(k) number

K261255

Applicant

Kowa Company, Ltd. Chofu Factory

Decision date

Sep 11, 2026

Date received

Apr 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MYC

Device type

Ophthalmoscope, Laser, Scanning

Device class

Class II

Regulation

21 CFR 886.1570

Advisory committee

Ophthalmic

Statement or summary

Summary

Third party

N

Location

Tokyo, JP