Duns Number:152165700
Device Description: A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery system A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
Catalog Number
-
Brand Name
Waterlase Laser Tips
Version/Model Number
Side Firing Tips
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2017
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
K161669,K161669,K161669,K161669
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
04501d73-742f-466d-8607-3b6e9e2e3b5b
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
April 17, 2017
Package DI Number
00647529003459
Quantity per Package
3
Contains DI Package
00647529003442
Package Discontinue Date
July 13, 2017
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |