Duns Number:152165700
Device Description: A therapeutic laser system intended for use in providing temporary relief of minor pain. A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Catalog Number
-
Brand Name
Epic T-Series Diode Laser System
Version/Model Number
7400055 Refurbished
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
7b5015ca-d56c-410d-9be2-82ae4f47e134
Public Version Date
July 29, 2020
Public Version Number
6
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 |