510(k) clearance

SLIT LAMP SL-D4 (Type: LED)

FDA 510(k) source

510(k) number

K262637

Applicant

Topcon Corporation

Decision date

Sep 18, 2026

Date received

Jul 29, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HJO

Device type

Biomicroscope, Slit-Lamp, Ac-Powered

Device class

Class II

Regulation

21 CFR 886.1850

Advisory committee

Ophthalmic

Statement or summary

Summary

Third party

N

Location

Tokyo, JP