Panels › Ophthalmic › Product code HJK · Class 2
Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation 886.1385
0510(k)s in 12 months (41 all time)
1recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in HJK
| Company | 510(k)s | Recalls |
|---|---|---|
| Ocular Instruments, Inc. | 25 | 0 |
| Volk Optical, Inc. | 4 | 2 |
| American Medical Devices, Inc. | 1 | 0 |
| Concept, Inc. | 1 | 0 |
| Dutch Ophthalmic Research Center (D.O.R.C.) | 1 | 0 |
| Fci Ophthalmics, Inc. | 1 | 0 |
| Haag-Streit USA, Inc. | 1 | 0 |
| Insight Instruments, Inc. | 1 | 0 |
| Insight International, Inc. | 1 | 0 |
| Luneau SA | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Vortex Surgical Inc. Volk Single Use Vitrectomy Lenses
1. Flat Vitrectomy Lens, Catalog VFD
2. Volk Magnifying Lens, Catalog VMD Open, Classified |
HJK | K050623 |
| Mar 15, 2016 | Volk Optical Inc Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602
for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, Terminated |
HJK | None listed |
| May 28, 2015 | Volk Optical Inc Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fund Terminated |
HJK | K023221 |
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