510(k) K162342 ยท HQC Unit, Phacofragmentation
Stellaris Elite Vision Enhancement System
| Applicant | Bausch+Lomb, St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Aug 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper. Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | None listed |
| Aug 8, 2018 | Bausch & Lomb Inc Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, Terminated |
HQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.