VelasmoothPro system FG70271

GUDID 07290109950532

VelasmoothPro System 100V, Packaged

SYNERON MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290109950532
NIH Device Record Key92593150-7295-4564-81b7-b048116fe6a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelasmoothPro system
Version Model NumberFG70271
Catalog NumberFG70271
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
GS107290109950532 [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 Date2016-10-09

On-Brand Devices [VelasmoothPro system]

07290109951508VelasmoothPro System 100V, Packaged
07290109951492VelasmoothPro System 115V, Packaged
07290109950549VelasmoothPro System 115V, Packaged
07290109950532VelasmoothPro System 100V, Packaged

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