Catalog Number

-

Brand Name

Soli-Lite LG4 Galileo

Version/Model Number

411569

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

K192755

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

e72e3e2c-955c-433b-93dc-49da17161b6c

Public Version Date

August 25, 2020

Public Version Number

1

DI Record Publish Date

August 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-