SEOULIN MEDICARE C · 89-08 · KOREA (THE REPUBLIC OF)

For SEOULIN MEDICARE C, 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 Sono Machine | Profacial solution | Plasma Machine | Sono Machine | Profacial solution | Plasma Machine | Sono Machine | Plasma Machine | Profacial solution; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 79 G - - FE Brush, Dermabrasion | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 02/09/2022; address is 4th Floor Seoulinglobal Center , 593-16 Dongtangiheung-Ro , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

SEOULIN MEDICARE C Date Published : 02/09/2022 4th Floor Seoulinglobal Center , 593-16 Dongtangiheung-Ro , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-22

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 2026-09-22

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.