Duns Number:436887608
Device Description: The SmartXide² system consists in a carbon dioxide laser (CO2) laser with 60W of maximum p The SmartXide² system consists in a carbon dioxide laser (CO2) laser with 60W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the Smartxide² system, having different spot sizes and high performances in specific application field.
Catalog Number
M103P1
Brand Name
DEKA SMARTXIDE²
Version/Model Number
M103P1
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
K133895
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
1f8099af-da5e-4112-816b-bde51fc6aaa5
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 13, 2016
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 |