Catalog Number

-

Brand Name

Waterlase Laser Tips

Version/Model Number

MX5

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

K090181,K090181

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

f5c914bc-3dcd-4b66-a221-b64d3f8379c0

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

00647529000946

Quantity per Package

2

Contains DI Package

00647529000526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box