Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
QWY · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QWY
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
HE
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Intended for use at the patients point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo.