Identity
- Trade Name
- WAVE ANALYZER MEDICA 800 FDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Device Name
- The WAM800 is a multifunctional ophthalmic device. There are several operation modes combined in a single platform : - Aberrometer - Autorefractometer keratometer - Corneal topographer - Tonometer - Pachymeter - Retro-illumination FDA UDI
- Model / Reference
- WAM800 FDA UDI
- Description
- The WAM800 is a multifunctional ophthalmic device. There are several operation modes combined in a single platform : - Aberrometer - Autorefractometer keratometer - Corneal topographer - Tonometer - Pachymeter - Retro-illumination FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000458 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 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: Automated ophthalmic refractometerOphthalmic tonometer, line-poweredCorneal topography systemCorneal topography system analyser
Wave Analyzer Medica 800 by Essilor International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bench-top keratometer.
- VERION™ — Alcon Laboratories, Inc. · Class I
- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- OPTICAL BIOMETER — Nidek, Inc. · Class II
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- OptochekPlus — REICHERT INC. · Class II
- OPTICAL BIOMETER — SANTEC CORPORATION · Class II
- Visionix — RIGHT MFG. CO., LTD. · Class I
- OPTICAL BIOMETER — Nidek, Inc. · Class II
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
- Essilor International
Sources (1)
- FDA UDI f07bcc0c-5977-4bab-8ccf-539d76e891fc 35 fields · synced May 30, 2026