Duns Number:152165700
Device Description: A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The sy A dental 980nm diode laser system intended for a variety of soft-tissue procedures. 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 foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Catalog Number
7410006
Brand Name
Epic Hygiene Diode Laser System
Version/Model Number
7410006
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
K192430
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
06f8954c-a3eb-4a4d-a0c8-b5e6a7e40e8d
Public Version Date
July 29, 2020
Public Version Number
2
DI Record Publish Date
December 21, 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 |