EOFE ULTRASONICS CO LTD · 89-08 · KOREA (THE REPUBLIC OF)

For EOFE ULTRASONICS CO LTD, import alert is 89-08; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device | ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device | ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device | ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device; product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 80 F - - LG Cleaner, Ultrasonic, Medical Instrument | 85 H - - GL Transducer, Ultrasonic, Obstetric | 90 I - - TX Transducer, Ultrasonic, Diagnostic; date published is 08/04/2023; address is 303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

EOFE ULTRASONICS CO LTD Date Published : 08/04/2023 303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.