Catalog Number

-

Brand Name

Waterlase Laser Tips

Version/Model Number

RFT2-21

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

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

K101658,K101658

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6ef7880e-e8f4-4556-9a06-5a7f736c8b49

Public Version Date

July 29, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

00647529001660

Quantity per Package

30

Contains DI Package

00647529001042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box