Duns Number:152165700
Device Description: A reusable hand-held device intended for use with Diode Laser Systems in tooth whitening p A reusable hand-held device intended for use with Diode Laser Systems in tooth whitening procedures. The device is used with disposable protective shields.
Catalog Number
-
Brand Name
Diode Laser System Whitening Handpiece
Version/Model Number
7400022 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
K121286
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
c3e3e5e8-61db-4ec8-8f4a-24bdaf3386fc
Public Version Date
July 29, 2020
Public Version Number
7
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 |