Clearance Summary
SER Pen Carain MicroSystem (MP1209SP) received FDA 510(k) clearance under submission number K253153, sponsored by Su-Ko Technologies, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-10-29.
- Submission: K253153
- Applicant / Sponsor: Su-Ko Technologies, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4430
- Decision date: 2025-10-29
Classification & Regulation
This clearance is catalogued under FDA product code QAI and 21 CFR 878.4430, within the General, Plastic Surgery review panel as a Class II device.