Catalog Number

-

Brand Name

SMOOTHSKIN

Version/Model Number

SmoothSkin Bare+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2023

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

-

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Public Device Record Key

516c1edd-fb61-4818-a71d-0080fa642b3b

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

March 19, 2020

Package DI Number

05060352782783

Quantity per Package

6

Contains DI Package

05060352782240

Package Discontinue Date

January 01, 2023

Package Status

In Commercial Distribution

Package Type

box