Clearance Summary
NeoSculpt Plus received FDA 510(k) clearance under submission number K252888, sponsored by S&M Medical Co., Ltd.. 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 2026-03-09.
- Submission: K252888
- Applicant / Sponsor: S&M Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2026-03-09
Classification & Regulation
This clearance is catalogued under FDA product code PBX and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.