Catalog Number

-

Brand Name

Laser Applicator Non-cooled

Version/Model Number

4017-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K163103,K201466,K163103,K201466

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

4c9b5dbc-2a44-458d-a023-fd2bbc0ebe90

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

December 18, 2020

Package DI Number

37340007000288

Quantity per Package

5

Contains DI Package

17340007000284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-