LightForce XPi

GUDID 00854103007103

Mains powered, infrared phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display. Compatible with New Empower IQ delivery system.

LITECURE LLC

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional
Primary Device ID00854103007103
NIH Device Record Key8e1d2e8e-42fc-4d1c-a17e-f28f22b385dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightForce XPi
Version Model NumberLTS-2500-L-S8
Company DUNS858768943
Company NameLITECURE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]
GS100854103007103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating
ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

Devices Manufactured by LITECURE LLC

00854103007097 - LightForce FXi2020-11-09 Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its batt
00854103007103 - LightForce XPi2020-11-09Mains powered, infrared phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display. Compatible with New Empower IQ delivery system.
00854103007103 - LightForce XPi2020-11-09 Mains powered, infrared phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen displ
00854103007059 - LightForce EXPi2020-03-31 Mains powered, infrared phototherapy and nail laser phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes w
00854103007073 - LightForce XLi2019-12-23 The LightForce XLi is a professional musculoskeletal/physical therapy laser emitting up to 40W at 810/980nm wavelengths. The Li
00854103007066 - SoLa Therapy Laser2019-06-28 Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
00854103007042 - LightForce FXi2019-05-07 Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its batte
00854103007004 - LightForce PRO2018-07-06 Mains powered, infrared phototherapy device emitting up to 9 W at 980 nm. The LightForce PRO (LTC-900) is indicated for emitti
00854103007011 - LightForce FX2018-07-06 Infrared phototherapy device emitting up to 15 W at 980 & 810 nm. The device can be powered through its battery pack or mains p

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