NeoSculpt Plus— 510(k) K252888

Name: FDA 510(k) clearance K252888
Creator: U.S. Food and Drug Administration
Published: 2026-03-09

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.

Summary

S&M Medical's NeoSculpt Plus is filed under PBX, radio frequency induced heat vacuum massagers. The record doesn't describe the device beyond its name and that code name.

Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).

S&M Medical filed from Gwangju, South Korea. Review took 180 calendar days (September 10, 2025 to March 9, 2026).

Clearance details

Applicant: S&M Medical Co., Ltd.
Product code: Product 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 ↗

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