510(k) K201285
K201285 is an FDA 510(k) premarket notification submitted by InMode , Ltd. for the device "InMode Evolve System with the Tone Applicator". The FDA issued a decision of Substantially Equivalent on March 5, 2021. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. InMode , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2021
- Date Received
- May 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type