FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AYON Body Contouring System (AYON SYSTEM)
K Number: K244050
·
Decision May 12, 2025
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
6
Review Days
132
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Basic Information
- Device Name
- AYON Body Contouring System (AYON SYSTEM)
- K Number
- K244050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apyx Medical Corporation
- Date Received
- December 31, 2024
- Decision Date
- May 12, 2025
- Product Code
- QPB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Apyx Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253396 | AYON Body Contouring System (AYON SYSTEM) | May 8, 2026 | Substantially Equivalent |
| K230586 | Renuvion® Micro Handpiece | Jun 9, 2023 | Substantially Equivalent |
| K230272 | Renuvion® APR Handpiece | Apr 27, 2023 | Substantially Equivalent |
| K223262 | Renuvion® APR Handpiece | Feb 23, 2023 | Substantially Equivalent |
| K221830 | Apyx One Console | Oct 11, 2022 | Substantially Equivalent |