Duns Number:858768943
Device Description: The LightForce XLi is a professional musculoskeletal/physical therapy laser emitting up to The LightForce XLi is a professional musculoskeletal/physical therapy laser emitting up to 40W at 810/980nm wavelengths. The LightForce XLi is indicated for emitting energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The XLi laser system includes a therapeutic laser console and optical delivery system. The optical delivery system consists of a flexible optical fiber connected to a hand piece with interchangeable treatment heads and provides motion feedback to the user. A custom software application allows the user to select from built-in treatment protocols that adjust dosage and wavelength based on patient characteristics and condition. The device also provides the ability to set custom treatment parameters including output power, treatment time, and pulse rate.
Catalog Number
-
Brand Name
LightForce XLi
Version/Model Number
LTS-4000-L
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
9e8924be-806e-43fd-b817-41fcccffedcf
Public Version Date
October 04, 2021
Public Version Number
2
DI Record Publish Date
December 13, 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. | 27 |