PBX

Massager, Vacuum, Radio Frequency Induced Heat

Product code
PBX
Device name
Massager, Vacuum, Radio Frequency Induced Heat
Device class
Class 2
21 CFR
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
79

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (18)

Last three years. Most recent: 2026-07-10.

NumberDecision dateApplicantDevice nameSummary
K2534802026-07-10Capenergy Medical S.L.Capenergy C Equipments RF C200 and C400 DrakarianPDF
K2606472026-04-02El.En S.P.A.SPECCHIOPDF
K2532612026-03-13Weero Co., Ltd.Apollo Quattro (APQ-10M)PDF
K2528882026-03-09S&M Medical Co., Ltd.NeoSculpt PlusPDF
K2507342025-09-10Pollogen, Ltd.OptiLUV DevicePDF
K2509162025-08-14Shenzhen Leaflife Technology Co., Ltd.WinForth (LM-E470KA)
K2437162025-05-28Termosalud S.L.Zionic Pro Max (Radiofrequency)PDF
K2417332025-04-16Novasonix Technology S.L.HEBE (NP0000763)PDF
K2430552025-04-15EMA Aesthetics , Ltd.Préime DermaFacial Collagen+
K2421752025-02-27Xod, Inc.XOD Diathermia Radiofrequency DevicePDF
K2411072025-01-24Indiba S. A. U.Indiba Diathermia Radiofrequency Deep Care Device (PDF
K2329662024-12-26Golden Star SrlFISIOWARM 7.0PDF
K2425532024-11-21General Vibronics, Inc.MIRARI® Cold Plasma System ( GV-M2-01)PDF
K2431642024-11-20Indiba S. A. U.INDIBA COMPACT devicesPDF
K2425982024-11-14InMode , Ltd.DEFINE System (AG612444A)PDF
K2409912024-10-09Weero Co., Ltd.eMVFit (MVF-10M)PDF
K2401782024-07-15Zimmer Medizinsysteme GmbHRFG-01PDF
K2307552023-10-30Bios S.R.L.NuEra Tight RF Model OptiStreamPDF

16 summaries are archived here for direct download.

Official FDA classification page: PBX
Classification and pathway per current FDA publications. Data from openFDA (CC0).