'CO2RE System, Packaged (Japan) FG70412JP

GUDID 07290109952765

'CO2RE System, Packaged (Japan)

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system
Primary Device ID07290109952765
NIH Device Record Key53ff89d6-88e6-4e70-92ae-a55d2c0f4e14
Commercial Distribution StatusIn Commercial Distribution
Brand Name'CO2RE System, Packaged (Japan)
Version Model NumberFG70412JP
Catalog NumberFG70412JP
Company DUNS532685716
Company NameSYNERON MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109952765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-08-30