Clearance Summary
Pixie Skin Tag received FDA 510(k) clearance under submission number K240226, sponsored by Oystershell NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-10-18.
- Submission: K240226
- Applicant / Sponsor: Oystershell NV
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class:
- Decision date: 2024-10-18
Classification & Regulation
This clearance is catalogued under FDA product code ORE , within the General, Plastic Surgery review panel as a device.