Device Dossier
Light therapy unit, photo
Device Dossier for Light therapy unit, photo (Light therapy unit, photo, Class IIa, sponsor GE Healthcare). ARTG record, intended purpose, GMDN category…
- GMDN category: Light therapy unit, photo
- Sponsor: GE Healthcare
Intended purpose
This LED Phototherapy System is intended to be used for the treatment of indirect hyper-bilirubinemia in term and pre-term infants, in a hospital environment ± NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. This device is intended for use under the direct supervision of a licensed healthcare practitioner. It is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.