# SUNWOO I&T · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For SUNWOO I&T · 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 Dermapen; product code is 79 G - - FE Brush, Dermabrasion; date published is 09/09/2013; address is 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** SUNWOO I&T _(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:** 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 09/09/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - FE Brush, Dermabrasion _(verified: appears in the quote below)_
- **Product:** Dermapen _(verified: appears in the quote below)_
- **FDA notes:** class II _(verified: appears in the quote below)_

## What the source says

> SUNWOO I&T Date Published : 09/09/2013 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF) 79 G - - FE Brush, Dermabrasion Date Published: 09/09/2013 Desc: Dermapen 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/).