EYEMERA Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For EYEMERA 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 Contact Lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear; date published is 12/26/2023; address is 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- 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
- 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu 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 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF) 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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