FDA product code QPB: System, Suction, Lipoplasty For Removal
QPB is the FDA product code for system, suction, lipoplasty for removal. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel. FDA has cleared 60 510(k) submissions under QPB, 13 in the last five years, from 39 different applicants. The average 510(k) review took 155 days (median 112); 247 days on average over the last three years. FDA has posted 1 recall for QPB devices, 1 initiated in the last five years.
Definition
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Classification
| Field | Value |
|---|---|
| Device name | System, Suction, Lipoplasty For Removal |
| Device class | Class II |
| Regulation | 21 CFR 878.5040 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QPB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 109 |
| 2019 | 2 | 57 |
| 2020 | 2 | 160 |
| 2022 | 2 | 300 |
| 2024 | 4 | 387 |
| 2025 | 2 | 124 |
| 2026 | 5 | 231 |
Compare with all 510(k) review times · Search every QPB clearance
Top QPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microaire Surgical Instruments, LLC | 6 | 2025-04-25 |
| Apyx Medical Corporation | 3 | 2026-08-21 |
| Black & Black Surgical, Inc. | 3 | 2024-09-13 |
| Sound Surgical Technologies, LLC | 3 | 2011-06-23 |
| Byron Medical | 3 | 2000-08-04 |
34 more applicants have QPB clearances. See the full list in Caduvo.
Most recent QPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254135 | NOUVAG AG | LipoSurg ARTIST | 2026-09-05 | 257 |
| K261710 | Apyx Medical Corporation | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | 2026-08-21 | 91 |
| K251944 | Lipocosm, LLC | Lipocosm Harmonic System | 2026-06-08 | 349 |
| K253396 | Apyx Medical Corporation | AYON Body Contouring System (AYON SYSTEM) | 2026-05-08 | 220 |
| K252495 | Newpong Co., Ltd. | LSSA (NP-200) | 2026-04-03 | 238 |
Recalls for QPB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-10-18.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code QPB?
QPB is the FDA product code for system, suction, lipoplasty for removal. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel.
What device class is QPB?
Class II, regulation 21 CFR 878.5040. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPB?
Across 60 cleared submissions the average was 155 days from receipt to decision (median 112).
Which companies have the most QPB clearances?
Microaire Surgical Instruments, LLC (6); Apyx Medical Corporation (3); Black & Black Surgical, Inc. (3); Sound Surgical Technologies, LLC (3); Byron Medical (3).
Have QPB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-10-18.
Next steps
- Run an FDA pathway report with predicate devices for product code QPB
- Run a recall and safety report across every QPB manufacturer
- Watch product code QPB 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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