Reference Source

LAON CO, LTD · 89-08 · KOREA (THE REPUBLIC OF)

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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