VelaSmooth Large applicator FG70301

GUDID 07290109951966

VelaSmooth Large Applicator (H)

SYNERON MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290109951966
NIH Device Record Keya5985aed-4719-4f1c-85b4-3e5ecef91460
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelaSmooth Large applicator
Version Model NumberFG70301
Catalog NumberFG70301
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109951966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUVMassager, Vacuum, Light Induced Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-25

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