Duns Number:436887608
Device Description: The DEKA Motus AY is a medical device quipped with a 755nm and 1064nm solid state laser so The DEKA Motus AY is a medical device quipped with a 755nm and 1064nm solid state laser sources. 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
M115B1
Brand Name
DEKA MOTUS AY
Version/Model Number
M115B1
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
K181486
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
6069d5da-6532-4384-a9a5-d9d968ca5647
Public Version Date
March 25, 2019
Public Version Number
1
DI Record Publish Date
March 15, 2019
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 |