510(k) clearance
SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
- 510(k) number
- K260387
- Applicant
- Hironic Co., Ltd.
- Decision date
- Aug 31, 2026
- Date received
- Feb 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NFO
- Device type
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device class
- Class II
- Regulation
- 21 CFR 882.5890
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Yongin-Si, CN