VISION SCIENCE CO · 89-08 · KOREA (THE REPUBLIC OF)
For VISION SCIENCE CO, 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 Dimplecolor colour lenses | Dimplecolor colour lenses | Dimplecolor colour lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - VN Lens, Contact (Disposable); date published is 01/20/2026; address is 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- VISION SCIENCE CO 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
- 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk KOREA (THE REPUBLIC OF) verified
- Date published
- 01/20/2026 verified
- Product code
- 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - VN Lens, Contact (Disposable) each item verified
- Product
- Dimplecolor colour lenses | Dimplecolor colour lenses | Dimplecolor colour lenses each item verified
- FDA notes
- labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). | labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). | labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). each item verified
What the source says
VISION SCIENCE CO Date Published : 01/20/2026 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk 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 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). 86 M - - VN Lens, Contact (Disposable) Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html