Duns Number:560439500
Device Description: Diode laser is intended to provide topical heating for the purpose of elevating tissue tem Diode laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, temporary increase local blood circulation and promoting relaxation of muscle
Catalog Number
Laser Therapy System
Brand Name
Laserconn
Version/Model Number
Theralas
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
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
2b96c95e-83ad-4cb8-ae58-cd64200c5d95
Public Version Date
July 06, 2021
Public Version Number
1
DI Record Publish Date
June 28, 2021
Package DI Number
16972558160028
Quantity per Package
1
Contains DI Package
06972558160021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |