Catalog Number

-

Brand Name

Biosonic

Version/Model Number

Facial Sculpting

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

K130065,K130065

Product Code

NFO

Product Code Name

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Public Device Record Key

882240b3-3605-429f-8c32-93db31b4e527

Public Version Date

August 21, 2018

Public Version Number

5

DI Record Publish Date

July 01, 2017

Package DI Number

10605580000425

Quantity per Package

1

Contains DI Package

00860558000422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-