Product Classification

• Device: skin microneedling manual/automated device (export only)
• Definition: For one-time (1X) use by qualified clinical professionals to cause bio-active effect(s) in skin for aesthetic improvement.
• Physical State: “Gamma Irradiated” Pouch containing Roller inside a colored Box and protective plastic holder, w/ IFU or System Kit w/ Key components of Re-usable Pen, one-time (1X) use/Disposable “Gamma Irradiated” Tip, Pen-Wall Power Adapter, w/ IFU.
• Technical Method: n/a
• Target Area: Skin on neck.
• Review Panel: General & Plastic Surgery
• Product Code: QQF
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Not Classified Reason: For Export Only
• Submission Type: Contact ODE
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible