Ugs · 89-08 · KOREA (THE REPUBLIC OF)
For Ugs, 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 Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color 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; date published is 04/30/2012; address is 302 Gwangwoo Bd 24-5 Jayang 4 Dong Gwang , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Ugs 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
- 302 Gwangwoo Bd 24-5 Jayang 4 Dong Gwang , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 04/30/2012 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 each item verified
- Product
- Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses | Color Contact Lenses each item verified
- FDA notes
- class II | class II | class II | class II | class II | Class II | class II | class II | class II each item verified
What the source says
Ugs Date Published : 04/30/2012 302 Gwangwoo Bd 24-5 Jayang 4 Dong Gwang , Seoul, 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: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 M - - VN Lens, Contact (Disposable) Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 04/30/2012 Desc: Color Contact Lenses Notes: class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 04/30/2012 Desc: Color 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