Duns Number:030124221
Device Description: A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use lin 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
Catalog Number
420060-AA
Brand Name
Beacon Advanced Energy CO2 Laser System
Version/Model Number
60 Watt
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180993
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
8ff38e0d-cbcb-4803-b993-e0e484bc10b6
Public Version Date
June 06, 2019
Public Version Number
2
DI Record Publish Date
July 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 60 |