510(k) K253396
- Device
- AYON Body Contouring System™ (AYON SYSTEM)
- Applicant
- Apyx Medical Corporation
- 510(k) number
- K253396
- Product code
- QPB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-08
- Date received
- 2025-09-30
- Regulation
- 878.5040
- Classification name
- System, Suction, Lipoplasty For Removal
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nikita Gajbhiye
- Address
- 5115 Ulmerton Rd. Clearwater FL US 33760 33760
FDA Registration Numbers#
- 1220246
- 3038715747
- 2435119
- 2022994
- 3022978896
- 1118193
- 1058584
- 3008717566
- 3007593903
- 3007697975
- 3002807523
- 3014903258
- 3003755939
- 1645337
- 3006611221
- 3004112621
- 3038613815
- 3011163668
- 3003587189
- 3030230686
- 3007279404
- 1313525
- 2523676
- 2028523
- 3009039068
- 3011533696
- 1000655158
- 3010400367
- 2020601
- 2027804
- 2030624
- 1047843
- 3018094310
- 2030580
- 3008837339
- 3006142527
- 3022320321
- 3004878380
- 1045254
- 3005670221
- 2032098
- 3011423170
- 3007829657
- 3009420598
- 1222928
- 3009103001
- 2032809
Source Documents#
Other 510(k) Records For Product Code QPB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252495 | LSSA (NP-200) | Newpong Co., Ltd. | 2026-04-03 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025-05-12 |
| K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | 2025-04-25 |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | 2024-12-30 |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | 2024-11-27 |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | 2024-09-13 |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | 2024-08-07 |
| K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | 2022-10-14 |
| K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022-06-10 |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020-05-14 |
| K200168 | Dermapose Access | Puregraft, LLC | 2020-04-22 |
| K190555 | PowerX Lipo System | Solta Medical | 2019-05-01 |
| K190551 | VASERlipo System | Solta Medical | 2019-05-01 |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017-10-13 |
| K170629 | VITRUVIAN INFILTRATION PUMP | Black & Black Surgical, Inc. | 2017-06-22 |