Duns Number:152165700
Device Description: iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue pr iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue procedures. The packaging contains one handpiece and accessories such as diode laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. iLase charging station is not included. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.
Catalog Number
-
Brand Name
iLase Handpiece
Version/Model Number
iLase Refurbished
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 11, 2018
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
K093852
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
deeaa965-2f2a-4e21-a613-374d945449d4
Public Version Date
July 29, 2020
Public Version Number
6
DI Record Publish Date
September 22, 2016
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 |