Silkro
FDA 510(k) K233123 · Hironic Co., Ltd.
510(k) numberK233123
Submission
- Device name
- Silkro
- Applicant
- Hironic Co., Ltd.
Yongin-Si, KR - Received
- September 27, 2023
- Decision date
- June 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K251334 | New Doublo 2.0GEI · Traditional | 09/29/2025SE |
| K241099 | Plasonic (Plasonic)GEI · Traditional | 11/08/2024SE |
| K210084 | SilkroGEI · Traditional | 06/03/2022SE |
| K201773 | PicohiGEX · Traditional | 10/19/2021SE |
| K192970 | SlimusPKT · Traditional | 12/01/2020SE |
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Questions and answers
When was Silkro cleared by the FDA?
Silkro (K233123) received a 510(k) decision of Substantially Equivalent on June 24, 2024, 271 days after the submission was received.
What is the product code of K233123?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.