510(k) K071043 ยท HQD Lens, Contact (Other Material) - Daily
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 2, 2007 |
| Received | Apr 12, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2018 | Alden Optical Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows:
Zenlens FT(Front Toric);
Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault);
Zenlens TPC-(T Terminated |
HQD | None listed |
| Jul 3, 2018 | Alden Optical Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows:
Zen RC TPC (Toric Peripheral Curve)
Zen RC FT (Front Toric Optics)
Catalog Number: AOZNT
Zenlen Terminated |
HQD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.