HANSATOME MICROKERATOME
FDA 510(k) clearance K010260 · decided 2001-04-27
Clearance details
- K-number
- K010260
- Device name
- HANSATOME MICROKERATOME
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-29
- Decision date
- 2001-04-27
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486) | Norwood Abbey , Ltd. | 2005-07-06 |
| EPI-K (K043183) | Moria SA | 2005-03-25 |
| AMADEUS II EPIKERATOME (K043150) | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
| MB 105 MILLENNIUM BLADES (K041110) | Millennium Biomedical, Inc. | 2004-10-13 |
Recalls involving this device
No recalls on record reference this clearance.
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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 |