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The Tracker / September 2026 / K262637

510(k) cleared

SLIT LAMP SL-D4 (Type: LED)

Topcon Corporation · Sep 18, 2026 · K262637

FDA cleared the SLIT LAMP SL-D4 (Type: LED) from Topcon Corporation on Sep 18, 2026 under K262637, a traditional 510(k). The device falls under product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered, regulated at 21 CFR 886.1850 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 29, 2026. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

Topcon Corporation has one other decision in the tracker over the last 12 months: K253039 (AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA).

Questions & Answers

What did FDA clear under K262637?

K262637 is the FDA 510(k) for SLIT LAMP SL-D4 (Type: LED), submitted by Topcon Corporation. FDA's decision date was Sep 18, 2026, under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered).

Who makes the SLIT LAMP SL-D4 (Type: LED)?

Topcon Corporation, based in Tokyo, is the applicant of record for K262637.

How long did the K262637 review take?

FDA received the submission on Jul 29, 2026 and issued its decision on Sep 18, 2026, 51 days later.

← All decisions in September 2026

Sources