Identity
- Trade Name
- VITRA 2 FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. FDA UDI
- Model / Reference
- VITRA 2 FDA UDI
- Description
- The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625569 FDA UDI
- 510(k) Number
- K191962 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
No
FDA UDI
Category: Ophthalmic solid-state laser system
Vitra 2 by Quantel Medical — 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
- Quantel Medical
Sources (1)
- FDA UDI 1ba4910b-a720-42ed-bd87-6ba016552c55 35 fields · synced May 30, 2026