Institute for Vision Improvement · 89-08 · SOUTH AFRICA
For Institute for Vision Improvement, import alert is 89-08; country is SOUTH AFRICA; 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 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 2026-09-30.
- 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
— 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html