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Fynelook

Shenzhen Dachi communication Co.,Ltd · Model EE0101 · UDI-DI 06979082450000

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

Recalls

Date	Firm	Reason
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA

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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.