Duns Number:152165700
Device Description: A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser- A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Catalog Number
7400042
Brand Name
Epic 10 Diode Laser System
Version/Model Number
7400042
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
K121286
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
ce3e89b5-96fa-4c70-a77a-f0bb226ae8ff
Public Version Date
July 29, 2020
Public Version Number
5
DI Record Publish Date
September 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |