Clearance Summary
Palm NRG cellulite and muscle toning body device received FDA 510(k) clearance under submission number K191940, sponsored by Heat IN A Click. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-11-03.
- Submission: K191940
- Applicant / Sponsor: Heat IN A Click
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2020-11-03
Classification & Regulation
This clearance is catalogued under FDA product code PBX and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.