Catalog Number

-

Brand Name

SMOOTHSKIN

Version/Model Number

SmoothSkin Pure Mini

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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

K213692,K213692

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Public Device Record Key

d8b1ec26-d9da-4dcd-b690-ca6da8b20d24

Public Version Date

May 27, 2022

Public Version Number

1

DI Record Publish Date

May 19, 2022

Package DI Number

05060352784329

Quantity per Package

6

Contains DI Package

05060352783308

Package Discontinue Date

January 01, 2025

Package Status

In Commercial Distribution

Package Type

box