IOLMASTER
FDA 510(k) clearance K993357 · decided 2000-03-20
Clearance details
- K-number
- K993357
- Device name
- IOLMASTER
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-06
- Decision date
- 2000-03-20
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Thornwood, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measureme recall (Z-0357-2016) | Carl Zeiss Meditec AG | 2015-12-01 |
| IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for recall (Z-0358-2016) | Carl Zeiss Meditec AG | 2015-12-01 |
| Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manuf recall (Z-0333-2014) | Carl Zeiss Meditec, Inc. | 2013-11-15 |
| Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is man recall (Z-0334-2014) | Carl Zeiss Meditec, Inc. | 2013-11-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |