510(k) K161461 ยท HQD Lens, Contact (Other Material) - Daily
BostonSight PD Prosthetic Device
| Applicant | Bostonsight, Needham MA, US |
| Decision | Substantially Equivalent, Jul 25, 2016 |
| Received | May 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2025 | Boston Foundation For Sight BostonSight PROSE Lens. Completed |
HQD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.