DEKA MOTUS AZ+ - The DEKA Motus AZ+ is a medical device equipped - EL.EN. SPA

Duns Number:436887608

Device Description: The DEKA Motus AZ+ is a medical device equipped with Alexandrite 755nm laser and Nd:YAG 10 The DEKA Motus AZ+ is a medical device equipped with Alexandrite 755nm laser and Nd:YAG 1064nm 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.

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More Product Details

Catalog Number

M130A1

Brand Name

DEKA MOTUS AZ+

Version/Model Number

M130A1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

c99eebb5-d010-45a5-a98d-686bc3105390

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EL.EN. SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46