LightForce XLi
Basic Information
- Brand Name
- LightForce XLi
- Primary DI
- 00854103007073
- Version / Model
- LTS-4000-L
- Company Name
- LITECURE LLC
- Labeler DUNS
- 858768943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-13
- Public Version
- 3
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 9e8924be-806e-43fd-b817-41fcccffedcf
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60409 | Musculoskeletal/physical therapy laser, professional | An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854103007073 | GS1 |