Identity
- Trade Name
- WAVELIGHT EX500 EXCIMER LASER FDA UDI
- Generic Name
- Ophthalmic excimer laser system FDA UDI
- Device Name
- WAVELIGHT EX500 EX LASER US FDA UDI
- Model / Reference
- 8065990794 FDA UDI
- Description
- WAVELIGHT EX500 EX LASER US FDA UDI
Identifiers
- Catalog Number
- 8065990794 FDA UDI
- Primary DI / UDI-DI
- 00380659907944 FDA UDI
- FDA Product Code
- LZS FDA UDI
- GMDN Term
- Ophthalmic excimer laser system FDA UDI
Classification
- Device Class
- Class III 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
Yes
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
Dimensions & Sizes
- Size
- Weight — 1200 Pound FDA UDI
Category: Ophthalmic excimer laser system
Wavelight Ex500 Excimer Laser by Alcon Laboratories, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 35057b0a-3a06-4173-9d96-f5c655d80948 36 fields · synced May 30, 2026