K230897 is an FDA 510(k) clearance for the Anterion. 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, 2023, 194 days after receiving the submission on March 31, 2023.
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 | K230897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2023 |
| Decision Date | October 11, 2023 |
| Days to Decision | 194 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. |