510(k) Report

510(k) · Cleared

Cleared

Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF

K013255510(k) TraditionalCleared Nov 7, 200140-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ellman Intl., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 7, 2001 as substantially equivalent to K001253 (Ellman Intl., Inc., 2000) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 1994. 104 later devices descend from it.

Decided
Nov 7, 2001
Review
40 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K933157 (1994). 2 ancestors in all. 104 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2013: 7 descendants cleared2020: 5 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2008: 2 descendants cleared2009: 3 descendants cleared2015: 5 descendants cleared2010: 6 descendants cleared2018: 5 descendants cleared2011: 2 descendants cleared2012: 3 descendants cleared2014: 4 descendants cleared2016: 7 descendants cleared2021: 3 descendants cleared2017: 7 descendants cleared2025: 11 descendants cleared2019: 2 descendants cleared2023: 5 descendants cleared2026: 8 descendants cleared2024: 9 descendants cleared2022: 8 descendants clearedK933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 28 descendants4 generations forward: 17 descendants5 generations forward: 25 descendants6 generations forward: 11 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19940+5
  1. Root · 1 generation backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. This deviceK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  3. Descendant · cites it directly · 56 of its ownK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 53 of its ownK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
  5. Descendant · 3 generations on · 52 of its ownK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
  6. Descendant · 2 generations on · 39 of its ownK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
  7. Descendant · cites it directly · 35 of its ownK061174 Surgi-MaxEllman Int'L, Inc. · 2006

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22009: 32010: 62011: 22012: 32013: 72014: 42015: 52016: 72017: 72018: 52019: 22020: 52021: 32022: 82023: 52024: 92025: 112026: 8
2005high 11 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 104 · See all
  • K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009 · cites it directly56descendants
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010 · 2 generations on53descendants
  • K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010 · 3 generations on52descendants
  • K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011 · 2 generations on39descendants
  • K061174Surgi-MaxEllman Int'L, Inc. · 2006 · cites it directly35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933157Erbotom Icc 200Erbe USA, Inc.1994—
0 (this device)K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001—
+1K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.20091
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.2010—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.2010—
+2K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.2011—
+1K061174Surgi-MaxEllman Int'L, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
200930
201060
201120
201230
201370
201440
201550
201670
201770
201850
201920
202050
202130
202280
202350
202490
2025110
202680
FIG. 1 — Lineage of K013255, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K001253Surgitron Iec II
Summary page 2
…with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage. 5. Identification to predicate devices 5.1.Sugitron IEC 11 with general use indication K001253 5.2 ERBOTOM ICC 200 with general use indication K933157 6. Summary of the technological characteristics of the new device in com…
Ellman Intl., Inc.2000—
*K933157Erbotom Icc 200
Summary page 2
…and turbinate shrinkage. 5. Identification to predicate devices 5.1.Sugitron IEC 11 with general use indication K001253 5.2 ERBOTOM ICC 200 with general use indication K933157 6. Summary of the technological characteristics of the new device in comparison to the predicate devices. Substantial equivalen…
Erbe USA, Inc.1994—

Also cleared against K001253: 3 other devices →

What descends from it? (104)

See all 104

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.200956
K061174Surgi-MaxEllman Int'L, Inc.200635
K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833
K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.201316
K051956DR. Oppel ST-501Sometech Incorporated20051
K200931RF Surgical GeneratorFulwell, LLC20200

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K082834 (Ellman Int'L, Inc., 2009) has gone furthest, with 56 descendants of its own.
  • 3 other devices also cite its predicate K001253.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

is idendical to the Surgitron as a preammendment device such as: * Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty, * Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional…

Read the full statement (133 words)

is idendical to the Surgitron as a preammendment device such as:

* Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,

* Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrncae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K001253

3 other devices cite the same predicate.

  • K030473Senorx ES-300Senorx, Inc. · 2003
  • K014290Entec Plasma WandsArthrocare Corp. · 2002
  • K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc. · 2001

More from Ellman Intl., Inc.

15 FDA decisions under this applicant name. See the company

  • K003126Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
  • K001986Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001407Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001253Surgitron Iec IIEllman Intl., Inc. · 2000
  • K992382Surgitron RadiolaseEllman Intl., Inc. · 1999

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https://510kreport.com/device/K013255 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013255

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026