Catalog Number

-

Brand Name

JOVS Graphene Hair Removal Device

Version/Model Number

JOC-910-Yellow

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2022

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K214113

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Public Device Record Key

91a3a8eb-de66-400c-88c9-86cc5fa46d0a

Public Version Date

September 16, 2022

Public Version Number

1

DI Record Publish Date

September 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-