Duns Number:436887608
Device Description: The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.The DEKA SmartXide² CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm.The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces.
Catalog Number
M103J1
Brand Name
DEKA SMARTXIDE²
Version/Model Number
M103J1
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
K113504
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
73ab6147-a7aa-446a-b2d2-c28a111218fb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2017
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. | 46 |