FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VISUREF 600
K Number: K253834
·
Decision Mar 18, 2026
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
1
Review Days
107
Basic Information
- Device Name
- VISUREF 600
- K Number
- K253834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Vision GmbH
- Date Received
- December 1, 2025
- Decision Date
- March 18, 2026
- Product Code
- HJO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HJO), ordered by most recent decision date.
HP-OCT (HP-OCT)
FDA 510(k)
FDA Class 2
·Ophthalmic
Kowa SL-19
FDA 510(k)
FDA Class 2
·Ophthalmic
MiiS Horus Eye Anterior Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Sunkingdom Slit Lamp
FDA 510(k)
FDA Class 2
·Ophthalmic
IOLMaster 700
FDA 510(k)
FDA Class 2
·Ophthalmic
SLM-1ER, SLM-2ER, SLM-3ER
FDA 510(k)
FDA Class 2
·Ophthalmic