LightForce EXP
Basic Information
- Brand Name
- LightForce EXP
- Primary DI
- 00854103007035
- Version / Model
- LTS-1500P
- Company Name
- LITECURE LLC
- Labeler DUNS
- 858768943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-07
- Public Version
- 5
- Public Version Date
- 2021-10-04
- Public Version Status
- Update
- Public Device Record Key
- 5860f6ab-29ba-4721-ac13-a3e17a353d59
Device Description
Mains powered, infrared and nail laser phototherapy device emitting up to 15 W at 810 & 980 nm and up to 25 W at 980 nm. At 810 & 980 nm, the LightForce EXP (LTS-1500P) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. At 980 nm, the EXP is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes, Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.). The EXP is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
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 |
|---|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | General, Plastic Surgery | 878.4810 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60388 | Nail laser phototherapy unit | A portable, mains electricity (AC-powered), laser-emitting device intended to treat nail fungal infection (onychomycosis) using low-level laser treatment (LLLT). It typically consists of an electronic unit with a digital display and a treatment platform where the foot/hand is placed to receive LLLT; it typically includes protective eyewear. It is intended to be used by a healthcare provider in a clinical setting. | No | Active |
| 35147 | Musculoskeletal infrared phototherapy unit, non-wearable | A mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854103007035 | GS1 |
Customer Contacts
- Phone
- 1-877-627-3858
- [email protected]