Duns Number:428482616
Device Description: Doctor Smile handpieces (LAFIO0025.1) are designed for a fast and easy connection to the l Doctor Smile handpieces (LAFIO0025.1) are designed for a fast and easy connection to the laser, for both dental and dermatological applications. They are autoclavable, light and manageable, for a perfect movement of the hand.
Catalog Number
LAFIO0025.1
Brand Name
Doctor Smile
Version/Model Number
Handpiece
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
K091562,K102036
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d3001032-ea67-417d-b36d-ddf60126b17f
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
December 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |