K201285 is an FDA 510(k) clearance for the InMode Evolve System with the 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 March 5, 2021, 296 days after receiving the submission on May 13, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K201285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 296 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 |