LSSA (NP-200)— 510(k) K252495

Name: FDA 510(k) clearance K252495
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Substantially Equivalent

Newpong Co., Ltd.

FDA 510(k) clearance K252495 for LSSA (NP-200), Substantially Equivalent on 2026-04-03. Applicant: Newpong Co., Ltd.. Device class: 2.

Summary

Newpong's LSSA (NP-200) is filed under product code QPB (System, Suction, Lipoplasty For Removal). The record doesn't spell out LSSA or describe the system beyond its name and that code name.

Class II, 21 CFR 878.5040. It came in as a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.

Newpong filed from Seoul, South Korea. Review took 238 calendar days (August 8, 2025 to April 3, 2026).

Clearance details

Applicant: Newpong Co., Ltd.
Product code: Product code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2025-08-08
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.