Catalog Number

7200891

Brand Name

Waterlase Laser Tips

Version/Model Number

Starter Kit

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

K101658

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

f79e3931-7d78-4782-b0c7-5ace3f735f85

Public Version Date

July 29, 2020

Public Version Number

4

DI Record Publish Date

May 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-