VISUREF 600— 510(k) K253834
Substantially EquivalentCarl Zeiss Vision GmbH
FDA 510(k) clearance K253834 for VISUREF 600, Substantially Equivalent on 2026-03-18. Applicant: Carl Zeiss Vision GmbH. Device class: 2.
Summary
Carl Zeiss Vision's VISUREF 600 is filed under HJO, AC-powered slit-lamp biomicroscopes. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 886.1850. It was a Traditional 510(k), and Ophthalmic is both the classification panel and the review panel.
Carl Zeiss Vision filed from Aalen, Germany. The decision came 107 calendar days after FDA received it (December 1, 2025 to March 18, 2026).
Clearance details
- Applicant
- Carl Zeiss Vision GmbH
- 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
- Aalen, DE
Recent devices under product code HJO
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