Duns Number:004053174
Device Description: VETERINARY - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes inductio VETERINARY - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger
Catalog Number
EVL
Brand Name
EVL
Version/Model Number
EVL
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NHN
Product Code Name
Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Public Device Record Key
aa0e9edd-26e7-4436-9b9e-eca8278c9769
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 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. | 15 |