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

For The Standard Company · 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 Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller; product code is 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen; date published is 11/29/2010; address is 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** The Standard Company _(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:** 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/29/2010 _(verified: appears in the quote below)_
- **Product code:** 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen _(verified: each item appears in the quote below)_
- **Product:** Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> The Standard Company Date Published : 11/29/2010 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF) 53 - - - -- Cosmetics Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 79 G - - ED Brush, Dermabrasion, Manual Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II

## 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/).