K192391 is an FDA 510(k) clearance for the Spectralis HRA+OCT and Variants. 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 September 26, 2019, 23 days after receiving the submission on September 3, 2019.
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 | K192391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | September 26, 2019 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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. |