Clearance Summary
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL received FDA 510(k) clearance under submission number K231073, sponsored by Esthetic Medical, Inc.. 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 2023-07-28.
- Submission: K231073
- Applicant / Sponsor: Esthetic Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4430
- Decision date: 2023-07-28
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.