Identity
- Trade Name
- BVI FDA UDI
- Generic Name
- Endoscopic-imaging ophthalmic solid-state laser system FDA UDI
- Device Name
- Leos laser and endoscopy system FDA UDI
- Model / Reference
- OME6000U FDA UDI
- Description
- Leos laser and endoscopy system FDA UDI
Identifiers
- Catalog Number
- OME6000U FDA UDI
- Primary DI / UDI-DI
- 00886158106609 FDA UDI
- FDA Product Code
- HQP FDA UDI
- GMDN Term
- Endoscopic-imaging ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4115 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: Endoscopic-imaging ophthalmic solid-state laser system
Bvi by Beaver-Visitec International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-imaging ophthalmic solid-state laser system.
- BVI — Beaver-Visitec International, Inc. · Class II
- Endo Optiks® — Beaver-Visitec International, 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
- Beaver-Visitec International, Inc.
Sources (1)
- FDA UDI e5479849-dc31-42b2-b3b5-a462f34d02c6 36 fields · synced May 30, 2026