Catalog Number

-

Brand Name

Stellar Optima™

Version/Model Number

Stellar Optima™

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

-

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,K193500

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

7ab42c14-4025-4583-af6b-4a62f1da6d19

Public Version Date

July 28, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-