K241267 is an FDA 510(k) clearance for the Hidroxa SE30. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Hidroxa Medical AB (Partille, SE). The FDA issued a Cleared decision on October 17, 2024, 164 days after receiving the submission on May 6, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K241267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2024 |
| Decision Date | October 17, 2024 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | EGJ - Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |