SPECTRALIS with Flex Module
FDA 510(k) clearance K241163 · decided 2024-10-11
Clearance details
- K-number
- K241163
- Device name
- SPECTRALIS with Flex Module
- Applicant
- Heidelberg Engineering GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-04-26
- Decision date
- 2024-10-11
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- OBO
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Heidelberg, 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 |
|---|---|---|
| SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (K253837) | Heidelberg Engineering GmbH | 2026-05-07 |
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| Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) | Tomey Corporation | 2025-07-18 |
| SPECTRALIS HRA+OCT and variants (K250868) | Heidelberg Engineering GmbH | 2025-05-12 |
| Anterion (K240924) | Heidelberg Engineering GmbH | 2024-12-13 |
| 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 |
| RESCAN 700 (K233421) | Carl Zeiss Meditec, AG | 2024-03-08 |
| 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.