Neo Vision Co Ltd · 89-08 · KOREA (THE REPUBLIC OF) (129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-do KOREA (THE REPUBLIC OF))
For Neo Vision Co Ltd (129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-do 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 | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight; date published is 11/09/2012; address is 129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Neo Vision 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
- 129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-do KOREA (THE REPUBLIC OF) verified
- Date published
- 11/09/2012 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort | 86 N - - UU Lens, Contact, Orthokeratology, Overnight each item verified
- Product
- Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses each item verified
- FDA notes
- class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. | class II; Soft contact lenses, daily wear are not subject to this import alert. each item verified
What the source says
Neo Vision Co Ltd Date Published : 11/09/2012 129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-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 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 M - - VN Lens, Contact (Disposable) Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert. 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html