510(k) K040204 ยท HNO Keratome, Ac-Powered
ZYOPTIX XP MICROKERATOME
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 22, 2004 |
| Received | Jan 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2008 | Bausch & Lomb Inc Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY. Terminated |
HNO | None listed |
| Oct 22, 2008 | Bausch & Lomb Inc Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Roches Terminated |
HNO | None listed |
| Aug 2, 2007 | Bausch & Lomb Inc Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactu Terminated |
HNO | None listed |
| Aug 2, 2007 | Bausch & Lomb Inc Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. Terminated |
HNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.