Catalog Number

-

Brand Name

Laser Applicator Non-cooled

Version/Model Number

4012-05

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

K151569,K201466,K151569,K201466,K151569,K201466

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6b84232e-3528-4239-89b6-9016f2cfd485

Public Version Date

October 10, 2022

Public Version Number

6

DI Record Publish Date

March 15, 2018

Package DI Number

57340007000497

Quantity per Package

2

Contains DI Package

37340007000493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-