Eyepia Medicals · 89-08 · KOREA (THE REPUBLIC OF)
For Eyepia Medicals · 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 09/21/2015; address is 3f 325-22 Danjeong Dont , Gyeonnggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- 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) 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 09/21/2015 Desc: Contact lenses Notes: Class II
— 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.