SLIT LAMP SL-D4 (Type: LED)— 510(k) K262637
Substantially EquivalentTopcon Corporation
FDA 510(k) clearance K262637 for SLIT LAMP SL-D4 (Type: LED), Substantially Equivalent on 2026-09-18. Applicant: Topcon Corporation. Device class: 2.
Summary
SLIT LAMP SL-D4 (Type: LED) is from Topcon Corporation, filed under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). The record doesn't describe the device beyond its name and code.
Class II, 21 CFR 886.1850. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Topcon filed from Tokyo, Japan. The decision came 51 calendar days after FDA received it (July 29 to September 18, 2026).
Clearance details
- Applicant
- Topcon Corporation
- Product code
- Product code HJO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.