Duns Number:152165700
Device Description: An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tiss An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
Catalog Number
7210001
Brand Name
Waterlase Express All-Tissue Laser System
Version/Model Number
7210001
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
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
618fb29c-e4bd-4880-8d43-3ee55d1fcd80
Public Version Date
July 29, 2020
Public Version Number
4
DI Record Publish Date
June 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |