# LAON CO, LTD · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For LAON 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 Microneedle Therapy System; product code is 80 M - - QX Needle, Acupuncture, Single Use; date published is 10/29/2013; address is Siwha Industrial Complex , 2172-5 Jeongwangng , Siheung, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** LAON 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:** Siwha Industrial Complex , 2172-5 Jeongwangng , Siheung, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/29/2013 _(verified: appears in the quote below)_
- **Product code:** 80 M - - QX Needle, Acupuncture, Single Use _(verified: appears in the quote below)_
- **Product:** Microneedle Therapy System _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> LAON CO, LTD Date Published : 10/29/2013 Siwha Industrial Complex , 2172-5 Jeongwangng , Siheung, KOREA (THE REPUBLIC OF) 80 M - - QX Needle, Acupuncture, Single Use Date Published: 10/29/2013 Desc: Microneedle Therapy System 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/).