Catalog Number

-

Brand Name

illuvinate Starter Kit

Version/Model Number

CAT0582

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173436

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

7e9129c7-e94b-48cb-8c13-c9b899648b60

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

March 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-