AccessGUDID - DEVICE: DEKA SMART US-20D (08057017760092)

GUDID

Device Identifier (DI) Information

Brand Name: DEKA SMART US-20D
Version or Model: M079B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M079B1
Company Name: EL.EN. SPA

Primary DI Number: 08057017760092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436887608 *Terms of Use

Device Description: The smart US-20D system consists in a carbon dioxide laser (CO2) with 25W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner).

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):	Yes
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?
61473	Dermatological carbon dioxide laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031440	000
K072159	000
K081181	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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 5 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 80 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: 1525975c-c4db-4295-947d-3a01cd4e9931
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: September 13, 2016