FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
PlaDuo System
K Number: K232223
·
Decision Oct 24, 2023
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- PlaDuo System
- K Number
- K232223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ShenB Co., Ltd.
- Date Received
- July 26, 2023
- Decision Date
- October 24, 2023
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ShenB Co., Ltd.
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|---|---|---|---|
| K253926 | Diacore | Apr 10, 2026 | Substantially Equivalent |
| K251649 | Sunny Plus (Sunny) | Sep 18, 2025 | Substantially Equivalent |
| K242241 | Sunny | Mar 19, 2025 | Substantially Equivalent |
| K241535 | Vybe RF II | Sep 25, 2024 | Substantially Equivalent |
| K230968 | VYBE RF Electrosurgical System | Jul 6, 2023 | Substantially Equivalent |
| K221363 | AF Laser | Jul 20, 2022 | Substantially Equivalent |
| K211562 | Virtue RF | Nov 23, 2021 | Substantially Equivalent |
| K193070 | VIVACE Electrosurgical Device | Apr 26, 2021 | Substantially Equivalent |
| K202415 | VirtueRF | Jan 22, 2021 | Substantially Equivalent |
| K201735 | PlaDuo System | Dec 14, 2020 | Substantially Equivalent |