K241163 is an FDA 510(k) clearance for the SPECTRALIS with Flex Module. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Heidelberg Engineering GmbH (Heidelberg, DE). The FDA issued a Cleared decision on October 11, 2024, 168 days after receiving the submission on April 26, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K241163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2024 |
| Decision Date | October 11, 2024 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |