COLORCLSHOP · 89-08 · KOREA (THE REPUBLIC OF)
For COLORCLSHOP, 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 - - 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 12/12/2023; address is COLORCL 351, SUNMOON-RO , TANGJEONG-MYEON , CHUNGCHEONGNAM-DO, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- COLORCLSHOP 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
- COLORCL 351, SUNMOON-RO , TANGJEONG-MYEON , CHUNGCHEONGNAM-DO, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/12/2023 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
- Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses each item verified
What the source says
COLORCLSHOP Date Published : 12/12/2023 COLORCL 351, SUNMOON-RO , TANGJEONG-MYEON , CHUNGCHEONGNAM-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 and Product
86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 12/12/2023 Desc: Contact Lenses 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 12/12/2023 Desc: Contact Lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 12/12/2023 Desc: Contact Lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 12/12/2023 Desc: Contact Lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 12/12/2023 Desc: Contact Lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 12/12/2023 Desc: Contact Lenses 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 12/12/2023 Desc: Contact Lenses 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 12/12/2023 Desc: Contact Lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 12/12/2023 Desc: Contact Lenses
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html