Submission Details
| 510(k) Number | K241267 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Hidroxa SE30
Oct 2024
Decision
164d
Days
Class 2
Risk
About This 510(k) Submission
K241267 is an FDA 510(k) clearance for the Hidroxa SE30, 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 review panel. Regulated under 21 CFR 890.5525.
Device Classification
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5525 |
Manufacturer
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