Identity
- Trade Name
- VISULAS green FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy. The DI number characterizes the laser slit lamp LSL green comfort. This laser slit lamp forms part of the model VISULAS green comfort. FDA UDI
- Model / Reference
- VISULAS green FDA UDI
- Description
- VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy. The DI number characterizes the laser slit lamp LSL green comfort. This laser slit lamp forms part of the model VISULAS green comfort. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471091427 FDA UDI
- 510(k) Number
- K181682 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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: General/multiple surgical frequency-doubled solid-state laser systemOphthalmic solid-state laser system
VISULAS green by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181682 also covers:
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 9b59bfc8-3c0f-404d-a5dc-7b4e225ee759 36 fields · synced May 30, 2026