Duns Number:436887608
Device Description: The DEKA Motus AZ is a medical device equipped with Alexandrite 755nm laser.The laser sour The DEKA Motus AZ is a medical device equipped with Alexandrite 755nm laser.The laser sources deliver 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.
Catalog Number
M130B1
Brand Name
DEKA MOTUS AZ
Version/Model Number
M130B1
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
K211821
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d3e5c69b-7691-444c-b36c-c2577edaccca
Public Version Date
April 13, 2022
Public Version Number
1
DI Record Publish Date
April 05, 2022
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 |