Catalog Number

-

Brand Name

iLightPro

Version/Model Number

iLightPro

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

K190938

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c06a30db-6579-4154-98d8-860a4a7be852

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-