Catalog Number

FG71201R

Brand Name

VelaShape III System 120V, Packaged

Version/Model Number

FG71201R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071872

Product Code

NUV

Product Code Name

Massager, Vacuum, Light Induced Heating

Public Device Record Key

7c12a9ac-31f1-4b1d-a0d1-02f38beaba85

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-