SEOULIN MEDICARE C · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- 4th Floor Seoulinglobal Center , 593-16 Dongtangiheung-Ro , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 02/09/2022 verified
- 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 each item verified
- Product
- Profacial solution | Sono Machine | Plasma Machine | Profacial solution | Sono Machine | Plasma Machine | Sono Machine | Profacial solution | Plasma Machine each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html