AirSculpt Body Contouring System (AIRS-1-SYS)
FDA 510(k) K241835 · Cellmyx
510(k) numberK241835
Submission
- Device name
- AirSculpt Body Contouring System (AIRS-1-SYS)
- Applicant
- Cellmyx
Carlsbad, CA, US - Received
- June 25, 2024
- Decision date
- November 27, 2024
- 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 |
| K240188 | Vitruvian LiposaberQPB · Traditional | Black & Black Surgical, Inc. | 09/13/2024SE |
| K212969 | LiposaverQPB · Traditional | Lhbiomed Co., Ltd. | 08/07/2024SE |
Questions and answers
When was AirSculpt Body Contouring System (AIRS-1-SYS) cleared by the FDA?
AirSculpt Body Contouring System (AIRS-1-SYS) (K241835) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 155 days after the submission was received.
What is the product code of K241835?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.