DEKA Smartlipo - The Smartlipo Laser is a Nd:YAG laser system. it - EL.EN. SPA

Duns Number:436887608

Device Description: The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.

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More Product Details

Catalog Number

M053Z1

Brand Name

DEKA Smartlipo

Version/Model Number

M053Z1

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

K062321

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

42a04bee-ddc5-463c-b1c6-9416f65f4cf3

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

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