SMARTSKIN+ - The Cynosure Smartskin+ system consists in a - EL.EN. SPA

Duns Number:436887608

Device Description: The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W of maximu The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through an handpiece or a scanning unit.

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More Product Details

Catalog Number

M079AZ1

Brand Name

SMARTSKIN+

Version/Model Number

M079AZ1

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

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

e2463b20-4aa0-4046-8ee6-2a325652b3e2

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2016

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