LightForce FXi

GUDID 00854103007097

Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its battery pack or mains power and has a 10" touch-screen display. Compatible with new empower delivery system with integrated emission control button and LED indicator.

LITECURE LLC

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Primary Device ID00854103007097
NIH Device Record Keydbe382ca-83be-4034-b955-72c4007c6062
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightForce FXi
Version Model NumberLTC-1510-L-B6
Company DUNS858768943
Company NameLITECURE LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100854103007097 [Primary]

FDA Product Code

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

On-Brand Devices [LightForce FXi]

00854103007042Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device
00854103007097Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device

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