BK261326- Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400)
The FDA has processed a regulatory action (BK261326) regarding the Viality Lipoaspirate Wash System (Viality-1400), which is indicated for filtering and washing aspirated, harvested, autologous adipose tissue for aesthetic body contouring.
Manufacturers of adipose tissue processing systems, surgical facilities performing autologous fat grafting, and regulatory professionals managing 510(k) or similarly cleared aesthetic devices.
The source specifically limits the intended use of this system to 'aesthetic body contouring' and specify it is for 'autologous adipose tissue.' This suggests that use in non-aesthetic applications or with non-autologous tissue would fall outside the cleared scope, requiring careful monitoring of label claims and marketing by compliance teams. The classification under the CBER (Vaccines, Blood & Biologics) pathway rather than CDRH for this specific adipose system may imply specific regulatory requirements for devices handling human cells or tissues.
Regulatory and QA teams should ensure that all internal processing protocols for the Viality-1400 align strictly with the specified filtering and washing parameters. Documentation should confirm that the system is only utilized for autologous adipose tissue intended for aesthetic body contouring as per the cleared indications.
The Viality™ Lipoaspirate Wash System is to be used to filter and wash aspirated, harvested, autologous adipose tissue for aesthetic body contouring.
Open in openFDA / FDA.gov