Psi-Tec Liposuction Aspirator
FDA 510(k) K981215 · Byron Medical
510(k) numberK981215
Submission
- Device name
- Psi-Tec Liposuction Aspirator
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- April 2, 1998
- Decision date
- July 1, 1998
- 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 |
|---|---|---|
| K040149 | Psi-Tec Peristaltic Infiltration PumpFRN · Traditional | 06/03/2004SE |
| K001803 | Accelerator Reciprocating CannulaQPB · Traditional | 08/04/2000SE |
| K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesQPB · Traditional | 06/30/1998SE |
| K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationFRN · Traditional | 06/16/1998SE |
| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K934233 | Zara Zone IV Malar Implant ModificationLZK · Traditional | 02/03/1994SE |
| K933670 | Biopsy Punch, SurgicalEME · Traditional | 01/07/1994SE |
Questions and answers
When was Psi-Tec Liposuction Aspirator cleared by the FDA?
Psi-Tec Liposuction Aspirator (K981215) received a 510(k) decision of Substantially Equivalent on July 1, 1998, 90 days after the submission was received.
What is the product code of K981215?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.