510(k) K260387
K260387 is an FDA 510(k) premarket notification submitted by Hironic Co., Ltd. for the device "SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)". The FDA issued a decision of Substantially Equivalent on August 31, 2026. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Hironic Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2026
- Date Received
- February 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type