Identity
- Trade Name
- WAVESCAN WAVEFRONT SYSTEM FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- ASSY, SYSTEM, WAVESCAN ACV FDA UDI
- Model / Reference
- 0070-1478 FDA UDI
- Description
- ASSY, SYSTEM, WAVESCAN ACV FDA UDI
Identifiers
- Catalog Number
- 0070-1478 FDA UDI
- Primary DI / UDI-DI
- 05050474573444 FDA UDI
- FDA Product Code
- LZS FDA UDI
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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: Automated ophthalmic refractometer
Wavescan Wavefront System by Johnson & Johnson Surgical Vision, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Johnson & Johnson Surgical Vision, Inc.
Sources (1)
- FDA UDI fb284f32-a291-4796-bdfe-b4b654a781c6 35 fields · synced Jun 9, 2026