# EOFE ULTRASONICS CO LTD · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For EOFE ULTRASONICS CO LTD · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; 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)"; country is KOREA (THE REPUBLIC OF); 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 2026-09-16.

- **Firm:** EOFE ULTRASONICS CO LTD _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/04/2023 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## What the source says

> EOFE ULTRASONICS CO LTD Date Published : 08/04/2023 303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF) 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 08/04/2023 Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device 80 F - - LG Cleaner, Ultrasonic, Medical Instrument Date Published: 08/04/2023 Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device 85 H - - GL Transducer, Ultrasonic, Obstetric Date Published: 08/04/2023 Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device 90 I - - TX Transducer, Ultrasonic, Diagnostic Date Published: 08/04/2023 Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).