Device Dossier
Photopheresis system lamp assembly
Device Dossier for Photopheresis system lamp assembly (Photopheresis system lamp assembly, Class IIb, sponsor Therakos). ARTG record, intended purpose,…
- GMDN category: Photopheresis system lamp assembly
- Sponsor: Therakos
Intended purpose
The THERAKOS™ CELLEX™ Photopheresis Light Assembly is to be used as part of the THERAKOS™ CELLEX™ Photopheresis System: For patients older than 18 years of age for the administration of photopheresis in the following: Cutaneous T Cell Lymphoma (CTCL) Solid Organ Transplant Rejection (SOT)(heart, lung) and For patients older than 3 years of age for the management of Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD).