Reference Source

Neo Vision Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)

For Neo Vision 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 | 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 93 Jeungsin-Ro , Icheon, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

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
93 Jeungsin-Ro , Icheon, Gyeonggi 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Neo Vision Co., Ltd. Date Published : 11/09/2012 93 Jeungsin-Ro , Icheon, Gyeonggi KOREA (THE REPUBLIC OF) 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.

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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