510(k) K191855
K191855 is an FDA 510(k) premarket notification submitted by Inmode MD , Ltd. for the device "EmFace Device". The FDA issued a decision of Substantially Equivalent on October 29, 2019. The device falls under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat), a Class II device regulated under 21 CFR 878.4400. Inmode MD , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2019
- Date Received
- July 10, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.