510(k) · Cleared
ClearedSYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hironic Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 6, 2026 as substantially equivalent to K241099 (Hironic Co., Ltd., 2024) after a 59-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Apr 6, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K933002 (1994). 32 ancestors in all, the oldest K823924 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 6 generations between
- 3 generations backK212329 Plasma IQNeauvia North America, Inc. · 2021
- 2 generations backK223222 Plasma IQNeauvia North America, Inc. · 2023
- 1 generation backK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- This deviceK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 9 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 8 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 7 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 6 generations backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- 5 generations backK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- 4 generations backK192813 Plasma IQNeauvia North America, Inc. · 2020
- 3 generations backK212329 Plasma IQNeauvia North America, Inc. · 2021
- 2 generations backK223222 Plasma IQNeauvia North America, Inc. · 2023
- 1 generation backK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- This deviceK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −9 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −8 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −7 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −6 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| −5 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| −4 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| −3 | K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 | — |
| −2 | K223222 | Plasma IQ | Neauvia North America, Inc. | 2023 | — |
| −1 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| 0 (this device) | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241099 | Plasonic (Plasonic)Summary page 5…er 878.4400 Product Code(s) GEl | Legally Marketed Predicate Devices 21 CFR 807.92(a)3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241099 PLASONIC GEl Device Description Summary 21 CFR 807.92(a)(4) The device is used in the removal and destruction of skin lesions an… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 32 ancestors have a recall of any class.
- 1 other device also cites its predicate K241099.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The device is used in the removal and destruction of skin lesions and coagulation of tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260397
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026