K251577 is an FDA 510(k) clearance for the LAIA XR. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Augmented Reality Software S.L. (Salamanca, ES). The FDA issued a Cleared decision on February 6, 2026, 260 days after receiving the submission on May 22, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K251577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2025 |
| Decision Date | February 06, 2026 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |