Catalog Number

111A

Brand Name

faceLITE

Version/Model Number

TN2010

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191629

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

ba9264e7-79a8-4f0d-81db-5d17c3966c44

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-