Cleared Traditional

Zionic Aesthetic

K230659 · Termosalud · General & Plastic Surgery
Jun 2023
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K230659 is an FDA 510(k) clearance for the Zionic Aesthetic, a Massager, Vacuum, Radio Frequency Induced Heat (Class II — Special Controls, product code PBX), submitted by Termosalud (Gijon, ES). The FDA issued a Cleared decision on June 8, 2023, 91 days after receiving the submission on March 9, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K230659 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2023
Decision Date June 08, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code PBX — Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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.