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

For M.I. TECH · 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 CytoPen Nano Pen | CytoPen Nano Pen; product code is 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device; date published is 04/12/2023; address is 65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** M.I. TECH _(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:** 65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/12/2023 _(verified: appears in the quote below)_
- **Product code:** 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device _(verified: each item appears in the quote below)_
- **Product:** CytoPen Nano Pen | CytoPen Nano Pen _(verified: each item appears in the quote below)_

## What the source says

> M.I. TECH Date Published : 04/12/2023 65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF) 79 G - - FE Brush, Dermabrasion Date Published: 04/12/2023 Desc: CytoPen Nano Pen 79 Q - - AI Powered microneedle device Date Published: 04/12/2023 Desc: CytoPen Nano Pen

## 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/).