Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device RECELL Autologous Cell Harvesting Device
Classification Namemechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator
Generic Namemechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator
Applicant
Avita Medical
28159 avenue stanford suite 220
Valencia, CA  91355 -2271
PMA NumberBP220799
Date Received12/19/2022
Decision Date06/16/2023
Decision Approved
Product Code
QWY[ Registered Establishments with QWY ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S004 S005 
-
-