510(k) K183167 ยท HQD Lens, Contact (Other Material) - Daily
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
| Applicant | Bausch & Lomb, Incorporated, Rochester NY, US |
| Decision | Substantially Equivalent, Feb 12, 2019 |
| Received | Nov 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183167
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.