DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4 - The Synchro Repla:y Excellium 3.4 is a medical - EL.EN. SPA

Duns Number:436887608

Device Description: The Synchro Repla:y Excellium 3.4 is a medical laser workstation equipped with an High pow The Synchro Repla:y Excellium 3.4 is a medical laser workstation equipped with an High power Alexandrite 755 nm laser and an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces.

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More Product Details

Catalog Number

M104K1

Brand Name

DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4

Version/Model Number

M104K1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K131095,K150516

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

f8c5783e-bbe7-41fd-9358-67820273cfa5

Public Version Date

July 06, 2018

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