510(k) · Cleared
ClearedRM STAR EX with RMS Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bomtech Electronics Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 26, 2024 as substantially equivalent to K213612 (VIOL Co., Ltd., 2022) after an 87-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Dec 26, 2024
- Review
- 87 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK172023 CelfirmVIOL Co., Ltd. · 2017
- 2 generations backK200185 Sylfirm XVIOL Co., Ltd. · 2020
- 1 generation backK213612 Sylfirm XVIOL Co., Ltd. · 2022
- This deviceK243097 RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 6 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 5 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 4 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 3 generations backK172023 CelfirmVIOL Co., Ltd. · 2017
- 2 generations backK200185 Sylfirm XVIOL Co., Ltd. · 2020
- 1 generation backK213612 Sylfirm XVIOL Co., Ltd. · 2022
- This deviceK243097 RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −6 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −5 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −4 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −3 | K172023 | Celfirm | VIOL Co., Ltd. | 2017 | — |
| −2 | K200185 | Sylfirm X | VIOL Co., Ltd. | 2020 | — |
| −1 | K213612 | Sylfirm X | VIOL Co., Ltd. | 2022 | — |
| 0 (this device) | K243097 | RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K213612 | Sylfirm XSummary page 5…: Class II Classification Panel: General and Plastic Surgery III. Legally Marketed Predicate Device Predicate #: K213612 Predicate Trade Name: SYLFIRM X IV. Device Description The RM STAR EX with RMS Needle includes a sys… | 2022 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 28 ancestors have a recall of any class.
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 RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243097: RM STAR EX with RMS Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243097
Report an extraction error
Are you the manufacturer?
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