K260397
- 510(k) number
- K260397
- Device name
- SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
- Applicant
- Hironic Co., Ltd. KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-04-06
- Date received
- 2026-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K260397.pdf
Official FDA record: K260397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.