K192249 is an FDA 510(k) clearance for the InMode System with Tone Applicator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Inmode , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on December 17, 2019, 120 days after receiving the submission on August 19, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K192249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2019 |
| Decision Date | December 17, 2019 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |