FDA gives OTC approval for Celluma light therapy device-BioPhotas
BioPhotas has announced it has received Over-The-Counter clearances by the FDA of the Celluma, its biophotonic medical light therapy device. The Celluma had been previously cleared for six separate Indications-For-Use on a Prescription basis, including the treatment of Acne, muscle and joint Pain, muscle and joint stiffness, muscle spasm, Arthritis and compromised local blood circulation. The company currently has a 510(k) application in with the FDA pursuing two additional dermatological Indications-For-Use in the area of skin rejuvenation.
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