Identity
- Trade Name
- WAVELIGHT ALLEGRO TOPOLYZER FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems. FDA UDI
- Model / Reference
- 8065990767 FDA UDI
- Description
- WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380659907678 FDA UDI
- FDA Product Code
- LZS FDA UDI
- GMDN Term
- Corneal topography 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 — 70.4 Pound FDA UDI
Category: Corneal topography system
Wavelight Allegro Topolyzer by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system.
- Tracey-VFA Visual Function Analyzer — Tracey Technologies, Corp. · Class I
- TOPOGRAPHIC MODELING SYSTEM — Tomey Corporation · Class I
- MYOPIA EXPERT 700 — VISIA IMAGING SRL · Class II
- Keratograph 5M — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- MYAH — VISIA IMAGING SRL · Class II
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- Topographic Modeling System — Tomey Corporation · Class I
- CASSINI — Cassini Technologies B.V. · Class I
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 d3b78a27-3884-46a9-b725-61399994b48e 35 fields · synced May 30, 2026