Identity
- Trade Name
- MYOPIA EXPERT 700 FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- BIOMETER - TOPOGRAPHER FDA UDI
- Model / Reference
- MYOPIA EXPERT 700 FDA UDI
- Description
- BIOMETER - TOPOGRAPHER FDA UDI
Identifiers
- Catalog Number
- BMT00004 FDA UDI
- Primary DI / UDI-DI
- 08034028770463 FDA UDI
- 510(k) Number
- K211868 FDA UDI
- FDA Product Code
- MXK FDA UDI
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class II 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
No
FDA UDI
Category: Corneal topography system
Myopia Expert 700 by Visia Imaging Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Keratograph 5M — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- WAVELIGHT ALLEGRO TOPOLYZER — Alcon Laboratories, Inc. · Class III
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- Topographic Modeling System — Tomey Corporation · Class I
- CASSINI — Cassini Technologies B.V. · Class I
- WAVE ANALYZER MEDICA 700 PLUS — ESSILOR INTERNATIONAL · Class II
Cleared under the same submission
K211868 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Visia Imaging Srl
Sources (2)
- FDA UDI 341087e5-27ce-4e42-8d0b-760a15c62660 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026