Identity
- Trade Name
- VISULAS 532s FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including: * Proliferative and nonproliferative diabetic retinopathy * Macular edema * Branch and central retinal vein occlusion * Lattice degeneration * Retinal tears and detachments FDA UDI
- Model / Reference
- VISULAS 532s, VISULAS 532s VITE FDA UDI
- Description
- The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including: * Proliferative and nonproliferative diabetic retinopathy * Macular edema * Branch and central retinal vein occlusion * Lattice degeneration * Retinal tears and detachments FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471091403 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic solid-state laser system
VISULAS 532s by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 703e809a-df0e-44b7-9563-24aeb4ec912a 36 fields · synced May 30, 2026