510(k) K050623 ยท HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
| Applicant | Volk Optical, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Mar 28, 2005 |
| Received | Mar 10, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050623
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.