Eyepia Medicals · 89-08 · KOREA (THE REPUBLIC OF)
For Eyepia Medicals, 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 09/21/2015; address is 3f 325-22 Danjeong Dont , Gyeonnggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Eyepia Medicals 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
- 3f 325-22 Danjeong Dont , Gyeonnggi-Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 09/21/2015 verified
- Product code
- 86 L - - PL Lenses, Soft Contact, Daily Wear verified
- Product
- Contact lenses verified
- FDA notes
- Class II verified
What the source says
Eyepia Medicals Date Published : 09/21/2015 3f 325-22 Danjeong Dont , Gyeonnggi-Do, 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: 09/21/2015 Desc: Contact lenses 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
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.