Identity
- Trade Name
- AMA Optics Vision Adaptor FDA UDI
- Generic Name
- Magnifying bar reader FDA UDI
- Device Name
- An ophthalmic device (a bar reader) consisting of a magnifying lens intended to magnify the print of reading material and to be used by a patient/person with impaired vision. The device is placed directly onto reading material which is read from above. It can be made of solid glass or plastic material. FDA UDI
- Model / Reference
- LVA-01 FDA UDI
- Description
- An ophthalmic device (a bar reader) consisting of a magnifying lens intended to magnify the print of reading material and to be used by a patient/person with impaired vision. The device is placed directly onto reading material which is read from above. It can be made of solid glass or plastic material. FDA UDI
Identifiers
- Catalog Number
- LVA01 FDA UDI
- Primary DI / UDI-DI
- G506LVA010 FDA UDI
- FDA Product Code
- HPE FDA UDI
- GMDN Term
- Magnifying bar reader FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5915 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Magnifying bar reader
AMA Optics Vision Adaptor by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- AMA Optics, Inc.
Sources (1)
- FDA UDI 7285b1eb-0003-4813-85ee-636cdfe1dd80 34 fields · synced Jun 1, 2026