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510(k) Data Aggregation
K Number
K072097Device Name
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
Manufacturer
MEDICAL SELECT, INC.
Date Cleared
2007-10-30
(91 days)
Product Code
LBI
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SELECT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.
Device Description
The BiliBee LED Phototherapy System is both a battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel for the treatment of neonatal jaundice (hyperbilirubinemia). Treatment is applied by placing the patient (neonate) on the BiliBee LED Phototherapy System panel with a disposable sheath separating the child from the panel's surface. The patient's eyes do not need to be covered during treatment. Treatment is intended to be applied 24 hours a day until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Treatment time is expected to range from 3 days to 3 weeks. Phototherapy treatment of neonatal jaundice using the BiliBee LED Phototherapy System can be applied at home or in a hospital.
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