EOFE ULTRASONICS CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- 303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF) verified
- Date published
- 08/04/2023 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html