Identity
- Trade Name
- Beacon Advanced Energy CO2 Laser System FDA UDI
- Generic Name
- General/multiple surgical diode/carbon dioxide laser system FDA UDI
- Device Name
- A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber FDA UDI
- Model / Reference
- 60 Watt FDA UDI
- Description
- A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber FDA UDI
Identifiers
- Catalog Number
- 420060-AA FDA UDI
- Primary DI / UDI-DI
- 00852306007715 FDA UDI
- 510(k) Number
- K180993 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical diode/carbon dioxide 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/carbon dioxide laser system
Beacon Advanced Energy CO2 Laser System by Omniguide, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Omniguide, Inc.
Sources (1)
- FDA UDI 8ff38e0d-cbcb-4803-b993-e0e484bc10b6 37 fields · synced May 30, 2026