RESCAN 700
FDA 510(k) clearance K233421 · decided 2024-03-08
Clearance details
- K-number
- K233421
- Device name
- RESCAN 700
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2023-10-10
- Decision date
- 2024-03-08
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- OBO
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jena, DE
- Third-party review
- No
- Expedited review
- No
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| SPECTRALIS HRA+OCT and variants (K250868) | Heidelberg Engineering GmbH | 2025-05-12 |
| Anterion (K240924) | Heidelberg Engineering GmbH | 2024-12-13 |
| SPECTRALIS with Flex Module (K241163) | Heidelberg Engineering GmbH | 2024-10-11 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (K241081) | Topcon Corporation | 2024-07-17 |
| SPECTRALIS HRA+OCT and variants (K240221) | Heidelberg Engineering GmbH | 2024-07-01 |
| CIRRUS™ HD-OCT Model 6000 (K233933) | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| P200TE (A10700) (K233602) | Optos Plc. | 2024-05-09 |
| 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (K233561) | Topcon Corporation | 2024-04-10 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222) | Topcon Corporation | 2023-10-30 |
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 |