Identity
- Trade Name
- VISIONIX FDA UDI
- Generic Name
- Automated lensmeter FDA UDI
- Model / Reference
- VX40 Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000602 FDA UDI
- FDA Product Code
- HLM FDA UDI
- GMDN Term
- Automated lensmeter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1425 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
Yes
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 lensmeter
Visionix by Luneau Technology Operations — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automated lensmeter.
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
- COMPUTERIZED LENSMETER CL-300 — Topcon Corp. · Class I
- Auto Lensmeter — Tomey Corporation · Class I
- MyRx LensScaner — 6 OVER 6 VISION LTD · Class I
- AUTO LENSMETER — Tomey Corporation · Class I
- TIANNUO / TNMED — Lianyungang Tiannuo Optical Instrument Co., Ltd. · Class I
- AUTO LENSMETER — Tomey Corporation · Class I
- Atlas — Eyoto, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (1)
- FDA UDI baab00cf-06b5-4dad-b637-d3e8aaaab8d5 32 fields · synced May 31, 2026