FDAnews
www.fdanews.com/articles/204611-koya-medical-gets-510k-clearance-for-lymphedema-and-venous-disease-treatment
ClearanceStamp_Orange.gif

Koya Medical Gets 510(k) Clearance for Lymphedema and Venous Disease Treatment

September 30, 2021

Koya Medical has received 510(k) clearance from the FDA for its Dayspring Lite treatment for lymphedema and venous disease.

The prescription-only treatment is for patients who need to add basic active compression to their lymphedema regimen. It uses the same technology and a smart, rechargeable, handheld controller as the company’s main Dayspring product.

Unlike standard compression pumps that require patients to be tethered during use, Dayspring treatments let patients move during their active compression therapy, the company said.

View today's stories