eMVFit (MVF-10M)— 510(k) K240991

Substantially Equivalent

Weero Co., Ltd.

FDA 510(k) clearance K240991 for eMVFit (MVF-10M), Substantially Equivalent on 2024-10-09. Applicant: Weero Co., Ltd.. Device class: 2.

Clearance details

Applicant: Weero Co., Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-04-11
Decision date: 2024-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon, 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
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Weero Co., Ltd.

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K241433 — EVE Synergy (EVE-20M)2025-06-04
K240992 — eMVFit (MVF-10M)2024-10-10

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