Catalog Number

LS03200

Brand Name

Diode laser FOX 1064 nm.

Version/Model Number

LS03200

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

K073322,K073322

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c7ad3669-e529-47b8-bc10-1af2a57f17a9

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 19, 2019

Package DI Number

04260155593024

Quantity per Package

1

Contains DI Package

04260155593017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-