Catalog Number

HU-FG00851US

Brand Name

Iluminage

Version/Model Number

HU-FG00851US

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

-

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

5f7e6904-9f84-4034-bb5b-1a3b622a561e

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

10806248005329

Quantity per Package

1

Contains DI Package

00806248005322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton