# SEOULIN MEDICARE C · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For SEOULIN MEDICARE C · 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 Profacial solution | Sono Machine | Plasma Machine | Profacial solution | Sono Machine | Plasma Machine | Sono Machine | Profacial solution | Plasma Machine; 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 2026-09-16.

- **Firm:** SEOULIN MEDICARE C _(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:** 4th Floor Seoulinglobal Center , 593-16 Dongtangiheung-Ro , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 02/09/2022 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** Profacial solution | Sono Machine | Plasma Machine | Profacial solution | Sono Machine | Plasma Machine | Sono Machine | Profacial solution | Plasma Machine _(verified: each item appears in the quote below)_

## 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) 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 02/09/2022 Desc: Profacial solution 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 02/09/2022 Desc: Sono Machine 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 02/09/2022 Desc: Plasma Machine 79 G - - FE Brush, Dermabrasion Date Published: 02/09/2022 Desc: Profacial solution 79 G - - FE Brush, Dermabrasion Date Published: 02/09/2022 Desc: Sono Machine 79 G - - FE Brush, Dermabrasion Date Published: 02/09/2022 Desc: Plasma Machine 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/09/2022 Desc: Sono Machine 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/09/2022 Desc: Profacial solution 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/09/2022 Desc: Plasma Machine

## 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/).