Catalog Number

HU-CO00621

Brand Name

Iluminage

Version/Model Number

HU-CO00621

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

e04a2ddf-892c-471b-ab8b-d2b64aace65a

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

10806248006333

Quantity per Package

1

Contains DI Package

00806248006336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton