Duns Number:436887608
Device Description: The Synchro Repla:y Premium 1.4.2 is a medical laser workstation equipped with an High pow The Synchro Repla:y Premium 1.4.2 is a medical laser workstation equipped with an High power Alexandrite 755 nm laser. The system can also be equipped with a pulsed light handpieces.
Catalog Number
M104J1
Brand Name
DEKA SYNCHRO REPLA:Y PREMIUM 1.4.2
Version/Model Number
M104J1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
5c6b3dbd-22ff-4e4b-adb0-96ad3eb8d048
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |