Duns Number:152165700
Device Description: A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Syst A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Systems. The tip is made of sapphire and is packaged individually in plastic cases.
Catalog Number
-
Brand Name
Waterlase Laser Tips
Version/Model Number
Side Firing Tips, SFT8-18
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
K161669,K161669,K161669
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
e8683cef-ee7f-46ae-aa4b-6c7623031f67
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
October 01, 2017
Package DI Number
00647529003626
Quantity per Package
2
Contains DI Package
00647529003602
Package Discontinue Date
-
Package Status
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 |