CALLISTO eye
FDA 510(k) clearance K231676 · decided 2023-08-28
Clearance details
- K-number
- K231676
- Device name
- CALLISTO eye
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2023-06-09
- Decision date
- 2023-08-28
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Jena, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZEISS CLINIC 360 (K260694) | Carl Zeiss Meditec, AG | 2026-07-17 |
| Harmony Referral System with Harmony OCT Viewer (Octave) (K253893) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 |
| iCare ALTIUS CW (K234076) | Centervue S.P.A. | 2024-08-22 |
| IMAGEnet6 Ophthalmic Data System (K232828) | Topcon Corporation | 2024-03-01 |
| CALLISTO eye (K232944) | Carl Zeiss Meditec, AG | 2023-12-21 |
| Harmony (K232555) | Topcon Healthcare Solutions | 2023-11-20 |
| Altris IMS (K232088) | Altris, Inc. | 2023-07-31 |
| Excelsior (K220929) | Merit Cro, Inc. | 2022-10-31 |
| FORUM (K213527) | Carl Zeiss Meditec, AG | 2022-08-15 |
| RetinAI Discovery (K211715) | Retinai Medical AG | 2022-04-28 |
| Harmony Referral System (K210396) | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
| CellChek 20 rc (K203244) | Konan Medical, Inc. | 2021-06-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048) | Carl Zeiss Meditec, AG | 2000-04-12 |
| MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079) | Carl Zeiss Meditec, AG | 1999-05-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077) | Carl Zeiss Meditec, AG | 1996-08-01 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075) | Carl Zeiss Meditec, AG | 1996-04-02 |