# DongBang Medical Co. Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For DongBang Medical Co. Ltd. · 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 Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical; date published is 10/22/2015; address is Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** DongBang Medical Co. Ltd. _(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:** Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/22/2015 _(verified: appears in the quote below)_
- **Product code:** 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical _(verified: each item appears in the quote below)_
- **Product:** Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle _(verified: each item appears in the quote below)_
- **FDA notes:** The device has no 510(k) clearance or PMA approval _(verified: appears in the quote below)_

## What the source says

> DongBang Medical Co. Ltd. Date Published : 10/22/2015 Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF) 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/21/2016 Desc: Derma-Q For Microneedle Notes: 79 G - - AB Needle, Suturing, Disposable Date Published: 10/22/2015 Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval 79 M - - DM Instrument, Manual, General Surgical Date Published: 04/21/2016 Desc: Derma-Q For Microneedle Notes:

## 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/).