FDA.reportPublic FDA data

LightForce EXPi

Primary DI
00854103007059
Brand
LightForce EXPi
Company
LITECURE LLC
Model
LTS-2500
Device description
"Mains powered, infrared phototherapy and nail laser phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10"" touch screen display. "
Published
2017-07-24
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
00854103007059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854103007059008541030070598541030070590854103007059

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

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
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
00854103007073LightForce XLiLTS-4000-L2019-12-13
00854103007066SoLa Therapy LaserLTC-1510-SOLA2019-06-20
00854103007042LightForce FXiLTC-15002017-07-24
00854103007332Large Massage BallPRD-000229-010-002022-11-22
00854103007349Flat WindowPRD-000233-0002022-11-22
00854103007318XL ConePRD-000644-0002022-08-23
00854103007325XL Rolling PinPRD-000721-0002022-08-23
00854103007110Empower Delivery SystemPRD-000424-010-01-L2022-06-30
00854103007134Empower IQ Delivery SystemPRD-000758-010-00-L2022-06-30
00854103007165Empower Delivery SystemPRD-000477-000-01-L2022-06-30
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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