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#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123014000LITECURE THERAPY SYSTEM MODEL LTS-1500Litecure, LLC2013-03-29PDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854103007035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854103007035008541030070358541030070350854103007035

GMDN Terms#

Term, Definition table
TermDefinition
Nail laser phototherapy unitA 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-627-3858customer.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 table
Primary DIBrandModelCatalogPublished
00854103007004LightForce PROLTC-9002017-02-07
00854103007011LightForce FXLTC-15002017-02-07
00854103007028LightForce EXLTS-15002017-02-07
00854103007295LightForce XLTC-1001-L-B62022-11-03
00854103007097LightForce FXiLTC-1510-L-B62020-10-30
00854103007103LightForce XPiLTS-2500-L-S82020-10-30
00854103007073LightForce XLiLTS-4000-L2019-12-13
00854103007066SoLa Therapy LaserLTC-1510-SOLA2019-06-20
00854103007042LightForce FXiLTC-15002017-07-24
00854103007059LightForce EXPiLTS-25002017-07-24
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00854103007172Empower Delivery SystemPRD-000477-000-02-L2022-06-30
00854103007189Empower Delivery SystemPRD-000477-000-03-L2022-06-30
00854103007196Empower Delivery SystemPRD-000477-000-04-L2022-06-30

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