PMA: BP170122 
Tradename: RECELL Autologous Cell Harvesting Device
Manufacturer: Avita Medical Americas, LLC
Indication:

• The RECELL Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL Device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

Product Information

• Instructions for Use - RECELL Autologous Cell Harvesting Device
• Procedure Guide - RECELL Autologous Cell Harvesting Device

Supporting Documents

• Summary of Safety and Effectiveness - RECELL Autologous Cell Harvesting Device
• June 9, 2021 Approval Order - RECELL Autologous Cell Harvesting Device
• September 20, 2018 Approval Order - RECELL Autologous Cell Harvesting Device
• Summary of Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device