PAL Multi-Use Cannulas and PAL Manual Wand
FDA 510(k) K171286 · Microaire Surgical Instruments, LLC
510(k) numberK171286
Submission
- Device name
- PAL Multi-Use Cannulas and PAL Manual Wand
- Applicant
- Microaire Surgical Instruments, LLC
Charlottesville, VA, US - Received
- May 1, 2017
- Decision date
- October 13, 2017
- 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 |
| K244026 | PAL 7020 ConsoleQPB · Traditional | Microaire Surgical Instruments, LLC | 04/25/2025SE |
| 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 |
More from Black & Black Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243589 | PAL Sterilization CaseKCT · Traditional | 06/20/2025SE |
| K244026 | PAL 7020 ConsoleQPB · Traditional | 04/25/2025SE |
| 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 |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU · Traditional | 05/22/2015SE |
Questions and answers
When was PAL Multi-Use Cannulas and PAL Manual Wand cleared by the FDA?
PAL Multi-Use Cannulas and PAL Manual Wand (K171286) received a 510(k) decision of Substantially Equivalent on October 13, 2017, 165 days after the submission was received.
What is the product code of K171286?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.