Device Dossier

Blue/red/infrared phototherapy lamp

Device Dossier for Blue/red/infrared phototherapy lamp (Blue/red/infrared phototherapy lamp, Class IIa, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The Celluma RESTORE is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2, or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV. The Celluma RESTORE device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, relieving stiffness; and to temporarily increase local blood circulation.

TGA Public Summary