VISION SCIENCE CO · 89-08 · KOREA (THE REPUBLIC OF)
For VISION SCIENCE CO · 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 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 2026-09-16.
- 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) 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).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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