Identity
- Trade Name
- WaveLight FDA UDI
- Generic Name
- Eye anterior segment analyser FDA UDI
- Device Name
- Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye. FDA UDI
- Model / Reference
- 1023 FDA UDI
- Description
- Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye. FDA UDI
Identifiers
- Catalog Number
- 8065998437 FDA UDI
- Primary DI / UDI-DI
- 00380659984372 FDA UDI
- FDA Product Code
- LZS FDA UDIMXK FDA UDI
- GMDN Term
- Eye anterior segment analyser FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.1850 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
Category: Eye anterior segment analyser
WaveLight 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 71e6683b-5efd-4687-88c5-9af1f9991e31 34 fields · synced Jun 1, 2026