Cleared Traditional

HEBE (NP0000763)

K241733 · Novasonix Technology S.L. · General & Plastic Surgery
Apr 2025
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K241733 is an FDA 510(k) clearance for the HEBE (NP0000763), a Massager, Vacuum, Radio Frequency Induced Heat (Class II — Special Controls, product code PBX), submitted by Novasonix Technology S.L. (Granollers, ES). The FDA issued a Cleared decision on April 16, 2025, 303 days after receiving the submission on June 17, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K241733 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2024
Decision Date April 16, 2025
Days to Decision 303 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.