Duns Number:152165700
Device Description: An assortment kit containing a combination of uninitiated and pre-initiated laser tips int An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.
Catalog Number
6400165
Brand Name
Diode Laser Tips
Version/Model Number
Diode Laser Tips - Starter Kit
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 20, 2019
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
Yes
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
K121286
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
2cb0a355-883d-4ab6-bf0a-1f797f42f645
Public Version Date
July 29, 2020
Public Version Number
2
DI Record Publish Date
December 19, 2019
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 |