SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
FDA 510(k) K260387 · Hironic Co., Ltd.
510(k) numberK260387
Submission
- Device name
- SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
- Applicant
- Hironic Co., Ltd.
Yongin-Si, CN - Received
- February 6, 2026
- Decision date
- August 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Shenzhen Nuon Medical Equipment Co., Ltd.
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| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)GEI · Traditional | 04/06/2026SE |
| K251334 | New Doublo 2.0GEI · Traditional | 09/29/2025SE |
| K241099 | Plasonic (Plasonic)GEI · Traditional | 11/08/2024SE |
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| 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 SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) cleared by the FDA?
SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) (K260387) received a 510(k) decision of Substantially Equivalent on August 31, 2026, 206 days after the submission was received.
What is the product code of K260387?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.