Institute for Vision Improvement · 89-08 · SOUTH AFRICA
For Institute for Vision Improvement · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; product is Lens; Spectacle; Non-Custom (Prescription) | Frame; Spectacle; product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle; date published is 08/15/2022; address is PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.
- Firm
- Institute for Vision Improvement 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
- SOUTH AFRICA verified
- Address
- PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA verified
- Date published
- 08/15/2022 verified
- Product code
- 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle each item verified
- Product
- Lens; Spectacle; Non-Custom (Prescription) | Frame; Spectacle each item verified
- FDA notes
- No 510K | No 510K each item verified
What the source says
Institute for Vision Improvement Date Published : 08/15/2022 PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 08/15/2022 Desc: Lens; Spectacle; Non-Custom (Prescription) Notes: No 510K 86 H - - QZ Frame, Spectacle Date Published: 08/15/2022 Desc: Frame; Spectacle Notes: No 510K
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.