FORUM
FDA 510(k) clearance K090439 · decided 2009-03-25
Clearance details
- K-number
- K090439
- Device name
- FORUM
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-02-20
- Decision date
- 2009-03-25
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dublin, CA, US
- Third-party review
- Yes
- Expedited review
- No
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| Harmony (K232555) | Topcon Healthcare Solutions | 2023-11-20 |
| CALLISTO eye (K231676) | Carl Zeiss Meditec, AG | 2023-08-28 |
| Altris IMS (K232088) | Altris, Inc. | 2023-07-31 |
| Excelsior (K220929) | Merit Cro, Inc. | 2022-10-31 |
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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 |