Manufacturer
Hironic Co., Ltd.SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260397
- Device name
- SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
- Company
- Hironic Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2026-02-06
- Decision date
- 2026-04-06
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The device is used in the removal and destruction of skin lesions and coagulation of tissue.
Intended Use
The device is used in the removal and destruction of skin lesions and coagulation of tissue.
Summary parsed at:2026-06-19 23:54:19 UTC
Predicate devices
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