PMA: BP220799
Tradename: RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)
Manufacturer: Avita Medical Americas, LLC
Indication:

• The RECELL Autologous Cell Harvesting Device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age and older. The RECELL Device is intended for use by an appropriately licensed and trained healthcare professional at the patient’s point-of-care for the safe and rapid preparation of Spray-On Skin Cells from a small sample of a patient’s own skin. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.

Product Information

• Instructions for Use - RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)

Supporting Documents

• June 16, 2023 Summary of Safety and Effectiveness Data (SSED) - RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)
• June 16, 2023 Approval Order - RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)