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,…
- GMDN category: Blue/red/infrared phototherapy lamp
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.