K243788 is an FDA 510(k) clearance for the IceCap product line. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Bioserenity Medical Devices Group (Paris, FR). The FDA issued a Cleared decision on March 13, 2025, 94 days after receiving the submission on December 9, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K243788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2024 |
| Decision Date | March 13, 2025 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |