IOLMaster700
FDA 510(k) clearance K143275 · decided 2015-07-10
Clearance details
- K-number
- K143275
- Device name
- IOLMaster700
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-14
- Decision date
- 2015-07-10
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VisuMax; VISUMAX 800 (P150040/S020) | Carl Zeiss Meditec, Inc. | 2025-12-18 |
| VISUMAX 800 Femtosecond Laser (P150040/S023) | Carl Zeiss Meditec, Inc. | 2025-10-16 |
| Visumax; VISUMAX 800 (P150040/S021) | Carl Zeiss Meditec, Inc. | 2025-08-21 |
| MEL 90 EXCIMER LASER SYSTEM (P060004/S009) | Carl Zeiss Meditec, Inc. | 2025-05-23 |
| MEL90 (P060004/S006) | Carl Zeiss Meditec, Inc. | 2024-12-04 |
| VisuMax Femtosecond Laser (P150040/S018) | Carl Zeiss Meditec, Inc. | 2024-10-16 |
| VisuMax (P150040/S016) | Carl Zeiss Meditec, Inc. | 2024-10-11 |
| VisuMax (P150040/S017) | Carl Zeiss Meditec, Inc. | 2024-05-23 |