FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SILKRO
K Number: K210084
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
8
Review Days
507
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Basic Information
- Device Name
- SILKRO
- K Number
- K210084
- 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
- Hironic Co., Ltd.
- Date Received
- January 12, 2021
- Decision Date
- June 3, 2022
- 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 Hironic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Apr 6, 2026 | Substantially Equivalent |
| K251334 | NEW DOUBLO 2.0 | Sep 29, 2025 | Substantially Equivalent |
| K241099 | Plasonic (Plasonic) | Nov 8, 2024 | Substantially Equivalent |
| K233123 | SILKRO | Jun 24, 2024 | Substantially Equivalent |
| K201773 | PICOHI | Oct 19, 2021 | Substantially Equivalent |
| K192970 | SLIMUS | Dec 1, 2020 | Substantially Equivalent |
| K173676 | A-FIT | Sep 14, 2018 | Substantially Equivalent |