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Euromi · Model Eva sp6 - 110V · UDI-DI 03701416203401

510(k) clearances

Adverse events

Recalls

Facilities

Description

Eva sp® 6 allows not only a quantitative nutational infrasonic infiltration but also a nutational infrasonic liposculpture. The advantages of the Eva sp® 6 are numerous: • Connective tissues are preserved: better skin retraction, less bleeding, oedema, bruising and pain. The recovery time is shorter. • The infiltration is constant, deep, homogeneous and controlled, regardless of the type of fat. • The infrasonic frequency (<25 Hz) is comfortable for the patient. • The work for the surgeon is easier and more precise. It is also shorter. • The surgeon has better access to delicate and difficult areas. • The Eva sp® 6 is compatible with N.L.F. System®

Recalls

Date	Firm	Reason
2024-10-18	HUMAN MED AG	The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spra

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.