LAON CO, LTD · 89-08 · KOREA (THE REPUBLIC OF)
For LAON CO, LTD, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- Firm
- LAON CO, LTD verified
- 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
- Address
- Siwha Industrial Complex , 2172-5 Jeongwangng , Siheung, KOREA (THE REPUBLIC OF) verified
- Date published
- 10/29/2013 verified
- Product code
- 80 M - - QX Needle, Acupuncture, Single Use verified
- Product
- Microneedle Therapy System verified
- FDA notes
- Class II verified
What the source says
LAON CO, LTD Date Published : 10/29/2013 Siwha Industrial Complex , 2172-5 Jeongwangng , Siheung, KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
80 M - - QX Needle, Acupuncture, Single Use Date Published: 10/29/2013 Desc: Microneedle Therapy System Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html