510(k) K230910 ยท HQD Lens, Contact (Other Material) - Daily
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
| Applicant | Acculens, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 16, 2023 |
| Received | Mar 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230910
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.