Lysonix Suction Lipoplasty System
FDA 510(k) K980771 · Lysonix, Inc.
510(k) numberK980771
Submission
- Device name
- Lysonix Suction Lipoplasty System
- Applicant
- Lysonix, Inc.
Carpinteria, CA, US - Received
- February 27, 1998
- Decision date
- July 13, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K980763 | Lysonix Lipoplasty Access PortQPB · Traditional | 05/28/1998SE |
| K980454 | Lysonix Aspiration PumpBTA · Traditional | 03/18/1998SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | 02/03/1998SE |
| K972958 | Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond CannulasGCJ · Traditional | 09/19/1997SE |
Questions and answers
When was Lysonix Suction Lipoplasty System cleared by the FDA?
Lysonix Suction Lipoplasty System (K980771) received a 510(k) decision of Substantially Equivalent on July 13, 1998, 136 days after the submission was received.
What is the product code of K980771?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.