DEKA LUXEA - The DEKA LUXEA is a versatile medical platform - EL.EN. SPA

Duns Number:436887608

Device Description: The DEKA LUXEA is a versatile medical platform that can be equipped with various types of The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces.Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application.The available handpieces are:- VIVID: 808±10 nm Laser- SPARKS: 1064nm Laser- PRISMA: 1064nm Q-Switched laser- VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter- LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters- RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter- LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filterEmission activation is either by footswitch or fingerswitch.Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.

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More Product Details

Catalog Number

M117B1

Brand Name

DEKA LUXEA

Version/Model Number

M117B1

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

K192539

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

14f3ca08-935b-4919-bf2e-442e93d6caa5

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