SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)— 510(k) K260387
Substantially EquivalentHironic Co., Ltd.
FDA 510(k) clearance K260387 for SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003), Substantially Equivalent on 2026-08-31. Applicant: Hironic Co., Ltd.. Device class: 2.
Summary
Hironic's submission lists three device names, SYNERJET PRO, InPhiuse, and WOWJET, each with model SP-1003. It's filed under product code NFO, transcutaneous electrical stimulators for aesthetic purposes.
Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
The record lists the applicant location as Yongin-Si, with country code CN. The decision, substantially equivalent, came 206 calendar days after receipt (February 6 to August 31, 2026).
Clearance details
- Applicant
- Hironic Co., Ltd.
- Product code
- Product code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yongin-Si, CN
Recent devices under product code NFO
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