U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)
  1. Approved Blood Products

RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102)

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

Supporting Documents

Back to Top