FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVAVA Skin Treatment System
K Number: K252155
·
Decision Oct 20, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
6
Review Days
103
Basic Information
- Device Name
- AVAVA Skin Treatment System
- K Number
- K252155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AVAVA, Inc.
- Date Received
- July 9, 2025
- Decision Date
- October 20, 2025
- Product Code
- ONG
- 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 |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
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Other Clearances by AVAVA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250402 | AVAVA Skin Treatment System | Apr 14, 2025 | Substantially Equivalent |
| K223871 | Miria Skin Treatment System | Jun 22, 2023 | Substantially Equivalent |
| K221268 | SR-1 Skin Treatment System | Nov 21, 2022 | Substantially Equivalent |
| K213726 | PL-1 Skin Treatment System | Jun 28, 2022 | Substantially Equivalent |
| K202884 | SR-1 Skin Treatment System | Apr 13, 2021 | Substantially Equivalent |