Catalog Number

-

Brand Name

STETIC SENSE

Version/Model Number

IPL-HQ3HU-SP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2019

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

K161565,K161565

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Public Device Record Key

83b02e75-e11b-499d-8c69-f2a5b55bb8a0

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

December 22, 2018

Package DI Number

16970821120052

Quantity per Package

4

Contains DI Package

06970821120055

Package Discontinue Date

December 22, 2019

Package Status

Not in Commercial Distribution

Package Type

-