Identity
- Trade Name
- neoV FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- neoV 810nm Laser System, 28W, 650nm aiming beam, SMA FDA UDI
- Model / Reference
- neoV810 FDA UDI
- Description
- neoV 810nm Laser System, 28W, 650nm aiming beam, SMA FDA UDI
Identifiers
- Catalog Number
- BG81001 FDA UDI
- Primary DI / UDI-DI
- 07290016629057 FDA UDI
- 510(k) Number
- K133006 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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: General/multiple surgical diode laser system
neoV by G.N.S Neolaser , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical diode laser system.
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Cleared under the same submission
K133006 also covers:
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
- neoV — G.N.S Neolaser , Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G.N.S Neolaser , Ltd.
Sources (1)
- FDA UDI 868d29e8-e2a8-42df-afa8-8dc3a485ab76 35 fields · synced Jun 1, 2026