FDA product code PBX: Massager, Vacuum, Radio Frequency Induced Heat
PBX is the FDA product code for massager, vacuum, radio frequency induced heat. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 79 510(k) submissions under PBX, 33 in the last five years, from 44 different applicants. The average 510(k) review took 184 days (median 174); 183 days on average over the last three years. FDA has posted 1 recall for PBX devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Massager, Vacuum, Radio Frequency Induced Heat |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PBX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 149 |
| 2018 | 3 | 98 |
| 2019 | 8 | 160 |
| 2020 | 8 | 178 |
| 2021 | 6 | 164 |
| 2022 | 7 | 281 |
| 2023 | 9 | 253 |
| 2024 | 6 | 172 |
| 2025 | 7 | 214 |
| 2026 | 4 | 162 |
Compare with all 510(k) review times · Search every PBX clearance
Top PBX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bios S.R.L. | 5 | 2023-10-30 |
| Venus Concept USA, Inc. | 5 | 2022-04-27 |
| Inmode MD , Ltd. | 5 | 2019-10-29 |
| BTL Industries, Inc. | 5 | 2019-03-29 |
| Cutera, Inc. | 5 | 2018-06-06 |
39 more applicants have PBX clearances. See the full list in Caduvo.
Most recent PBX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253480 | Capenergy Medical S.L. | Capenergy C Equipments RF C200 and C400 Drakarian | 2026-07-10 | 269 |
| K260647 | El.En S.P.A. | SPECCHIO | 2026-04-02 | 34 |
| K253261 | Weero Co., Ltd. | Apollo Quattro (APQ-10M) | 2026-03-13 | 165 |
| K252888 | S&M Medical Co., Ltd. | NeoSculpt Plus | 2026-03-09 | 180 |
| K250734 | Pollogen, Ltd. | OptiLUV Device | 2025-09-10 | 183 |
Recalls for PBX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-07-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PBX?
PBX is the FDA product code for massager, vacuum, radio frequency induced heat. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is PBX?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBX?
Across 79 cleared submissions the average was 184 days from receipt to decision (median 174).
Which companies have the most PBX clearances?
Bios S.R.L. (5); Venus Concept USA, Inc. (5); Inmode MD , Ltd. (5); BTL Industries, Inc. (5); Cutera, Inc. (5).
Have PBX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PBX
- Run a recall and safety report across every PBX manufacturer
- Watch product code PBX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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