K150453 is an FDA 510(k) clearance for the TULA Iontophoresis System with Earset. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on May 20, 2015, 89 days after receiving the submission on February 20, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K150453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2015 |
| Decision Date | May 20, 2015 |
| Days to Decision | 89 days |
| Submission Type | Special |
| 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 |