ZYOPTIX XP MICROKERATOME
FDA 510(k) clearance K040204 · decided 2004-03-22
Clearance details
- K-number
- K040204
- Device name
- ZYOPTIX XP MICROKERATOME
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-29
- Decision date
- 2004-03-22
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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| ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465) | Bausch & Lomb, Inc. | 2006-09-06 |
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| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufa recall (Z-0103-2009) | Bausch & Lomb Inc | 2008-10-22 |
| Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one o recall (Z-0104-2009) | Bausch & Lomb Inc | 2008-10-22 |
| Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reord recall (Z-1021-2007) | Bausch & Lomb Inc | 2007-08-02 |
| Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reu recall (Z-1022-2007) | Bausch & Lomb Inc | 2007-08-02 |
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| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |