LightForce XLi

Primary DI
00854103007073
Brand
LightForce XLi
Company
LITECURE LLC
Model
LTS-4000-L
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.
Published
2019-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173067000LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC2018-02-22GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854103007073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854103007073008541030070738541030070730854103007073

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn 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), improving 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 internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Sterilization Methods#

Method table
Method

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 table
Primary DIBrandModelCatalogPublished
00854103007004LightForce PROLTC-9002017-02-07
00854103007011LightForce FXLTC-15002017-02-07
00854103007028LightForce EXLTS-15002017-02-07
00854103007035LightForce EXPLTS-1500P2017-02-07
00854103007295LightForce XLTC-1001-L-B62022-11-03
00854103007097LightForce FXiLTC-1510-L-B62020-10-30
00854103007103LightForce XPiLTS-2500-L-S82020-10-30
00854103007066SoLa Therapy LaserLTC-1510-SOLA2019-06-20
00854103007042LightForce FXiLTC-15002017-07-24
00854103007059LightForce EXPiLTS-25002017-07-24
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00854103007189Empower Delivery SystemPRD-000477-000-03-L2022-06-30
00854103007196Empower Delivery SystemPRD-000477-000-04-L2022-06-30

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