PBXClass II

Massager, Vacuum, Radio Frequency Induced Heat

21 CFR 878.4400 / General, Plastic Surgery

PBX is the FDA product code for Massager, Vacuum, Radio Frequency Induced Heat, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 79 510(k) clearances under this code, the most recent dated 2026-07-10, and one recall.

Classification record

Product code: PBX
Device name: Massager, Vacuum, Radio Frequency Induced Heat
FDA 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.
Regulation: 21 CFR 878.4400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 80
Ingested recalls: 1

Clearances, product code PBX

By decision year

80 clearances under product code PBX with a decision year between 2012 and 2026, 2023 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code PBX by decision year
Year	Clearances
2012	1
2014	2
2015	5
2016	7
2017	6
2018	3
2019	8
2020	8
2021	6
2022	7
2023	9
2024	6
2025	7
2026	5

Applicants with the most clearances

Product code PBX

Applicants holding the most 510(k) clearances under product code PBX
Applicant	Clearances
BTL Industries, Inc	5
Bios S.r.l.	5
Cutera Inc	5
Inmode MD, Ltd.	5
Venus Concept USA Inc.	5
Capenergy Medical, S.L.	3
Swims America Corp	3
Viora, Ltd.	3
Cao Group, Inc.	2
El Global Trade Ltd.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order