Lutronic 'CoreRevi' Obtains US FDA 510k Clearance

Lutronic's hospital medical device 'Corelevi'

[Asia Economy Reporter Chunhee Lee] Aesthetic medical device company Lutronic announced on the 18th that its hospital-use medical device ‘CoreLevee’ recently obtained the 510k (pre-market approval) from the U.S. Food and Drug Administration (FDA). It has been about one year since the approval application was submitted in November last year. After approximately one year of review, the approval was completed.

CoreLevee is currently renamed as 'Accucurv' in South Korea and Europe. A Lutronic official stated, "We plan to change the model name in the U.S. as well," adding, "This 510k approval is not limited to the U.S. market but aims to expand the base of overseas markets accessible through FDA approval.”

CoreLevee is a medical device that generates a high-intensity magnetic field to apply the electromagnetic field to the patient's affected area. It allows intensity adjustment for precise treatment tailored to individual patients and is a non-invasive method enabling treatment while wearing clothes, thus providing high patient convenience.

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