EYEMERA CO LTD · 89-08 · KOREA (THE REPUBLIC OF) (Dalseo Gu , Seoul , Doum 5-Ro, KOREA (THE REPUBLIC OF))
For EYEMERA CO LTD (Dalseo Gu , Seoul , Doum 5-Ro, KOREA (THE REPUBLIC OF)), 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 Contact Lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear; date published is 12/26/2023; address is Dalseo Gu , Seoul , Doum 5-Ro, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- EYEMERA 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
- Dalseo Gu , Seoul , Doum 5-Ro, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/26/2023 verified
- Product code
- 86 L - - PL Lenses, Soft Contact, Daily Wear verified
- Product
- Contact Lenses verified
- FDA notes
- Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing. verified
What the source says
EYEMERA CO LTD Date Published : 12/26/2023 Dalseo Gu , Seoul , Doum 5-Ro, 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
86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 12/26/2023 Desc: Contact Lenses Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html