Duns Number:514489314
Device Description: The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral and maxillofacial surgery and dentistry.This product is a kit that contains consul,applicator and an accessory kit.
Catalog Number
LI-FG0012A
Brand Name
LiteTouch
Version/Model Number
LI-FG0012A
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
K061966
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
036f0678-0a87-46cf-a57a-9687a678e1d0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 01, 2017
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. | 4 |