NeoSculpt Plus— 510(k) K252888

Substantially Equivalent

S&M Medical Co., Ltd.

FDA 510(k) clearance K252888 for NeoSculpt Plus, Substantially Equivalent on 2026-03-09. Applicant: S&M Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: S&M Medical Co., Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-09-10
Decision date: 2026-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangju, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K250734 — OptiLUV Device2025-09-10
K250916 — WinForth (LM-E470KA)2025-08-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.