Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
FDA 510(k) clearance K231075 · decided 2023-06-20
Clearance details
- K-number
- K231075
- Device name
- Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-14
- Decision date
- 2023-06-20
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| EXPLORER AIR® II (K222240) | Surgvision GmbH | 2023-02-28 |
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| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MEL 90 Excimer Laser (P060004/S010) | Carl Zeiss Meditec, Inc. | 2026-07-01 |
| VISUMAX 800 Femtosecond Laser (P150040/S024) | Carl Zeiss Meditec, Inc. | 2026-05-26 |
| Visumax Femtosecond Laser (P150040/S025) | Carl Zeiss Meditec, Inc. | 2026-05-20 |
| MEL 90 Excimer Laser (P060004/S011) | Carl Zeiss Meditec, Inc. | 2026-04-30 |
| 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 |