Catalog Number

L200001

Brand Name

Lasermach PRO

Version/Model Number

WLA-01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191611

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

d0604276-28be-4eaf-8c68-54274f192db3

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-