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

Duns Number:436887608

Device Description: The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an high powe The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

M104L1

Brand Name

DEKA SYNCHRO REPLA:Y EXCELLIUM HP

Version/Model Number

M104L1

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

e5da9042-1920-4806-9044-f0e36ac7a9c5

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