Duns Number:858768943
Device Description: Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The d Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its battery pack or mains power and has a 10" touch-screen display.
Catalog Number
-
Brand Name
LightForce FXi
Version/Model Number
LTC-1500
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
5772802d-6555-4cbb-b5a9-aa936b24af80
Public Version Date
May 07, 2019
Public Version Number
5
DI Record Publish Date
July 24, 2017
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. | 27 |