VASERlipo System
FDA 510(k) K190551 · Solta Medical
510(k) numberK190551
Submission
- Device name
- VASERlipo System
- Applicant
- Solta Medical
Bothell, WA, US - Received
- March 5, 2019
- Decision date
- May 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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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 |
|---|---|---|
| K242142 | Fraxel® FTX Laser SystemGEX · Traditional | 08/21/2024SE |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser SystemGEX · Traditional | 12/29/2022SE |
| K190555 | PowerX Lipo SystemQPB · Special | 05/01/2019SE |
| K173759 | Thermage CPT System and AccessoriesGEI · Special | 01/08/2018SE |
| K170758 | Thermage FLX System and AccessoriesGEI · Traditional | 09/22/2017SE |
| K132431 | Thermage CPT SystemGEI · Special | 09/06/2013SE |
| K130193 | Fraxel Dual 1550/1927 Laser SystemGEX · Traditional | 06/14/2013SE |
| K121515 | Isolaz 2 Intense Pulsed Light SystemONF · Special | 06/05/2012SE |
| K120433 | Clear + Brilliant Laser SystemONG · Special | 04/02/2012SE |
| K110349 | Clear+Brilliant Laser SystemONG · Traditional | 05/03/2011SE |
Questions and answers
When was VASERlipo System cleared by the FDA?
VASERlipo System (K190551) received a 510(k) decision of Substantially Equivalent on May 1, 2019, 57 days after the submission was received.
What is the product code of K190551?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.