510(k) · Cleared
Recalled · Class II · 2016Surgitron 4.0 Dual RF S5-Iec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman International, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 12, 2013 as substantially equivalent to K013255 (Ellman Intl., Inc., 2001) and 1 other predicate after a 254-day review. Its family tree reaches back 12 generations to 1995. 16 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2013
- Review
- 254 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 12 generations to K943450 (1995). 30 ancestors in all, the oldest K800617 (1980). 16 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK040135 Thermage Thermacool SystemThermage, Inc. · 2004
- 1 generation backK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · Recalled
- This deviceK123366 Surgitron 4.0 Dual RF S5-IecEllman International, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK182365 TempSure SystemCynosure, Inc. · 2018
- Descendant · 2 generations on · 14 of its ownK190678 TempSureCynosure, Inc. · 2019
- Descendant · 3 generations on · 13 of its ownK200241 TempSure SystemCynosure, LLC · 2020
- Descendant · 4 generations on · 7 of its ownK211639 BTL-785WBTL Industries, Inc. · 2022
- Descendant · 5 generations on · 5 of its ownK222556 BTL-785XBTL Industries, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK040135 Thermage Thermacool SystemThermage, Inc. · 2004
- 1 generation backK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · Recalled
- This deviceK123366 Surgitron 4.0 Dual RF S5-IecEllman International, Inc. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K182365TempSure SystemCynosure, Inc. · 2018 · cites it directly15descendants
- K190678TempSureCynosure, Inc. · 2019 · 2 generations on14descendants
- K200241TempSure SystemCynosure, LLC · 2020 · 3 generations on13descendants
- K211639BTL-785WBTL Industries, Inc. · 2022 · 4 generations on7descendants
- K222556BTL-785XBTL Industries, Inc. · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K040135 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −1 | K082834 | Ellman International Non-Ablative Technique for Surgitron Iec | Ellman Int'L, Inc. | 2009 | 1 |
| 0 (this device) | K123366 | Surgitron 4.0 Dual RF S5-Iec | Ellman International, Inc. | 2013 | — |
| +1 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| +2 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| +3 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
| +4 | K211639 | BTL-785W | BTL Industries, Inc. | 2022 | — |
| +5 | K222556 | BTL-785X | BTL Industries, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | 2001 |
| * | K082834 | Ellman International Non-Ablative Technique for Surgitron IecSummary page 1…Class 11, 21 CFR 878.4400, Product Code GEl Predicate Devices: Ellman International - Surgitron 120 IEC (Surgitron 4.0 Dual RF) (KO 13255, K082834) Device Description: The Surgitron 4.0 Dual RI S5 - lEG is a radiofrequency energy generator employed for a variety of electrosu… | 2009 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182365 | TempSure System | 2018 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2016 | Class II | Z-0748-2017 | Employee error | Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K182365 (Cynosure, Inc., 2018) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K013255.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Surgitron 4.0 Dual RF S5 - IEC is indicated for: * Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes II-V * Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. *…
Read the full statement (150 words)
The Surgitron 4.0 Dual RF S5 - IEC is indicated for:
* Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes II-V
* Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
* Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
* Hemostasis: control of bleeding, epilation, telangiectasia.
* Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
* Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123366: Surgitron 4.0 Dual RF S5-Iec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123366
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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