QWY — Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator Class III

FDA Device Classification

FDA product code QWY covers "Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator", a Class III medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
QWY
Device Class
Class III
Regulation Number
Submission Type
Review Panel
HE
Medical Specialty
Unknown
Implant
No

Definition

Intended for use at the patient’s 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.