AccessGUDID - DEVICE: DEKA Motus AX (08057017760221)

GUDID

Device Identifier (DI) Information

Brand Name: DEKA Motus AX
Version or Model: M112B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M112B1
Company Name: EL.EN. SPA

Primary DI Number: 08057017760221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436887608 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47883	Dermatological solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162886	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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