LightForce EXP
- Primary DI
- 00854103007035
- Brand
- LightForce EXP
- Company
- LITECURE LLC
- Model
- LTS-1500P
- 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.
- Published
- 2017-02-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K123014 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00854103007035 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00854103007035 | 00854103007035 | 854103007035 | 0854103007035 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-877-627-3858 | customer.service@litecure.com |
Regulatory Flags#
- DUNS number
- 858768943
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00854103007004 | LightForce PRO | LTC-900 | 2017-02-07 | |
| 00854103007011 | LightForce FX | LTC-1500 | 2017-02-07 | |
| 00854103007028 | LightForce EX | LTS-1500 | 2017-02-07 | |
| 00854103007295 | LightForce X | LTC-1001-L-B6 | 2022-11-03 | |
| 00854103007097 | LightForce FXi | LTC-1510-L-B6 | 2020-10-30 | |
| 00854103007103 | LightForce XPi | LTS-2500-L-S8 | 2020-10-30 | |
| 00854103007073 | LightForce XLi | LTS-4000-L | 2019-12-13 | |
| 00854103007066 | SoLa Therapy Laser | LTC-1510-SOLA | 2019-06-20 | |
| 00854103007042 | LightForce FXi | LTC-1500 | 2017-07-24 | |
| 00854103007059 | LightForce EXPi | LTS-2500 | 2017-07-24 | |
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