510(k) · Cleared
ClearedPlasonic (Plasonic)
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 Nov 8, 2024 as substantially equivalent to K223222 (Neauvia North America, Inc., 2023) and 2 other predicates after a 200-day review. Its family tree reaches back 9 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 8, 2024
- Review
- 200 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K933002 (1994). 31 ancestors in all, the oldest K823924 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 5 generations between
- 3 generations backK192813 Plasma IQNeauvia North America, Inc. · 2020
- 2 generations backK212329 Plasma IQNeauvia North America, Inc. · 2021
- 1 generation backK223222 Plasma IQNeauvia North America, Inc. · 2023
- This deviceK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 8 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 7 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 6 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 5 generations backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- 4 generations backK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- 3 generations backK192813 Plasma IQNeauvia North America, Inc. · 2020
- 2 generations backK212329 Plasma IQNeauvia North America, Inc. · 2021
- 1 generation backK223222 Plasma IQNeauvia North America, Inc. · 2023
- This deviceK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −8 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −7 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −6 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −5 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| −4 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| −3 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| −2 | K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 | — |
| −1 | K223222 | Plasma IQ | Neauvia North America, Inc. | 2023 | — |
| 0 (this device) | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +1 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026 | — |
| +1 | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K223222 | Plasma IQSummary page 5…Review Panel General & Plastic Surgery (ODE) 3. Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3) Predicate Device – 1 K223222 Applicant: Neauvia North America, Inc Trade/Device Name: Plasma IQ… | 2023 |
| * | K230472 | Sonopuls 190Summary page 5…and Accessories Regulatory Class: Class II Product Code: GEI Predicate Device - 2 K230472 Applicant: Enraf-Nonius, B.V. Trade/Device Name: Sonopuls 190… | 2023 |
| * | K161628 | JAS Pulse (TM) Ultrasonic TherapySummary page 5…tion Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Predicate Device - 3 K161628 Applicant: Bonutti Research, Inc. Trade/Device Name: JAS Pulse™ Ult… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K260397 (Hironic Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.
The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241099: Plasonic (Plasonic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241099
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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