Polytouch Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Polytouch 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 | Contact Lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 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 11/20/2014; address is 108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Polytouch 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
- 108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/20/2014 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 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 | Contact Lenses each item verified
- FDA notes
- Class 2 | class 2 | class 2 | class 2 | class 2 | class 2 | class 2 | class 2 | class 2 | class 2 each item verified
What the source says
Polytouch Co Ltd Date Published : 11/20/2014 108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA (THE REPUBLIC OF) 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 11/20/2014 Desc: Contact Lenses Notes: Class 2 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 M - - VN Lens, Contact (Disposable) Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 11/20/2014 Desc: Contact Lenses Notes: class 2
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html