Duns Number:688409662
Device Description: K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLA K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLATION AND COAGULATION OFORAL SOFT TISSUE PROCEDURES, INCLUDING TOOTH WHITENING AND THE TEMPORARY RELIEF OF PAIN.
Catalog Number
-
Brand Name
K2 MOBILE
Version/Model Number
K2 MOBILE
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
K200693
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
8f46421c-9916-4fad-afa4-d8482dd171b9
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 2022
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. | 1 |