Submission Details
| 510(k) Number | K252923 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
IASIS i2 Relaxation Neurofeedback System
Mar 2026
Decision
179d
Days
—
Risk
About This 510(k) Submission
K252923 is an FDA 510(k) clearance for the IASIS i2 Relaxation Neurofeedback System, submitted by Iasis Technologies (Murrieta, US). The FDA issued a Cleared decision on March 13, 2026, 179 days after receiving the submission on September 15, 2025. This device falls under the Neurology review panel.
Device Classification
| Product Code | — |
| Device Class | — |