Catalog Number

-

Brand Name

Stellar Optima Treatment Kit

Version/Model Number

Stellar Optima Treatment Kit

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2021

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

Yes

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

DEN200028,DEN200028

Product Code

QIU

Product Code Name

Intense Pulsed Light Device For Managing Dry Eye

Public Device Record Key

90e29ad9-cca0-4347-945e-9e8e72d37b75

Public Version Date

July 28, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2021

Package DI Number

17290109145126

Quantity per Package

48

Contains DI Package

07290109145129

Package Discontinue Date

July 27, 2021

Package Status

Not in Commercial Distribution

Package Type

-