510(k) K262637
K262637 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "SLIT LAMP SL-D4 (Type: LED)". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Topcon Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2026
- Date Received
- July 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type