PAL 7020 Console
FDA 510(k) K244026 · Microaire Surgical Instruments, LLC
510(k) numberK244026
Submission
- Device name
- PAL 7020 Console
- Applicant
- Microaire Surgical Instruments, LLC
Charlottesville, VA, US - Received
- December 30, 2024
- Decision date
- April 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QPB – System, Suction, Lipoplasty For Removal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Other 510(k)s with product code QPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254135 | LipoSurg ARTISTQPB · Traditional | Nouvag AG | 09/05/2026SE |
| K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula AdaptorsQPB · Traditional | Apyx Medical Corporation | 08/21/2026SE |
| K251944 | Lipocosm Harmonic SystemQPB · Traditional | Lipocosm, LLC | 06/08/2026SE |
| K253396 | AYON Body Contouring System (AYON SYSTEM)QPB · Traditional | Apyx Medical Corporation | 05/08/2026SE |
| K252495 | Lssa (NP-200)QPB · Traditional | Newpong Co., Ltd. | 04/03/2026SE |
| K244050 | AYON Body Contouring System (AYON SYSTEM)QPB · Traditional | Apyx Medical Corporation | 05/12/2025SE |
| K242804 | PAL Aspiration SystemQPB · Traditional | Microaire Surgical Instruments, LLC | 12/30/2024SE |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS)QPB · Traditional | Cellmyx | 11/27/2024SE |
| K240188 | Vitruvian LiposaberQPB · Traditional | Black & Black Surgical, Inc. | 09/13/2024SE |
| K212969 | LiposaverQPB · Traditional | Lhbiomed Co., Ltd. | 08/07/2024SE |
More from Lhbiomed Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243589 | PAL Sterilization CaseKCT · Traditional | 06/20/2025SE |
| K242804 | PAL Aspiration SystemQPB · Traditional | 12/30/2024SE |
| K223406 | SmartRelease Endoscopic Soft Tissue Release SystemHRX · Traditional | 02/02/2023SE |
| K220318 | PAL Infiltration SystemQPB · Traditional | 10/14/2022SE |
| K212024 | PAL SystemQPB · Traditional | 06/10/2022SE |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release SystemHRX · Traditional | 06/24/2021SE |
| K192694 | PAL Single-Use CannulasQPB · Traditional | 05/14/2020SE |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release SystemHRX · Traditional | 11/06/2018SE |
| K171286 | PAL Multi-Use Cannulas and PAL Manual WandQPB · Traditional | 10/13/2017SE |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU · Traditional | 05/22/2015SE |
Questions and answers
When was PAL 7020 Console cleared by the FDA?
PAL 7020 Console (K244026) received a 510(k) decision of Substantially Equivalent on April 25, 2025, 116 days after the submission was received.
What is the product code of K244026?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.