Duns Number:436887608
Device Description: The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source.The l The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source.The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.Handpiece activation is either by footswitch or fingerswitch.
Catalog Number
M112B1
Brand Name
DEKA Motus AX
Version/Model Number
M112B1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162886
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
9b21ffa3-f8db-4c6f-af37-582739e19bf2
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
July 03, 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 |