510(k) Report

510(k) · Cleared

Recalled · 2012

Ellman International Non-Ablative Technique for Surgitron Iec

K082834510(k) TraditionalCleared May 7, 2009223-day reviewClass II21 CFR 878.4400Recalls 1

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

Ellman Int'L, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 7, 2009 as substantially equivalent to K013255 (Ellman Intl., Inc., 2001) and 1 other predicate after a 223-day review. Its family tree reaches back 11 generations to 1995. 56 later devices descend from it. It has been recalled once.

Decided
May 7, 2009
Review
223 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
2

Its longest line of descent runs back 11 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). 56 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 3 other ancestors1994: 3 other ancestors1999: 1 other ancestor1996: 5 other ancestors1980: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors2011: 1 descendant cleared2013: 5 descendants cleared2010: 2 descendants cleared2015: 2 descendants cleared2025: 9 descendants cleared2018: 3 descendants cleared2016: 3 descendants cleared2017: 4 descendants cleared2023: 5 descendants cleared2019: 1 descendant cleared2024: 8 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2026: 6 descendants cleared2021: 2 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K040135 · Thermage Thermacool System · Thermage, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors6 generations back: 7 other ancestors7 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 13 descendants5 generations forward: 9 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K040135 · Thermage Thermacool System · Thermage, Inc. · 2004K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50+5
  1. Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 7 generations between
  3. 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  4. 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  5. 1 generation backK040135 Thermage Thermacool SystemThermage, Inc. · 2004
  6. This deviceK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009
  7. Descendant · cites it directly · 53 of its ownK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
  8. Descendant · 2 generations on · 52 of its ownK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
  9. Descendant · cites it directly · 39 of its ownK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
  10. Descendant · 2 generations on · 17 of its ownK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
  11. Descendant · 2 generations on · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
Show all 11 generations
  1. Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 7 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 6 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 5 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 4 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 1 generation backK040135 Thermage Thermacool SystemThermage, Inc. · 2004
  12. This deviceK082834 Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 2009

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2010: 22011: 12013: 52015: 22016: 32017: 42018: 32019: 12020: 12021: 22022: 42023: 52024: 82025: 92026: 6
2010high 9 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 56 · See all
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010 · cites it directly53descendants
  • K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010 · 2 generations on52descendants
  • K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011 · cites it directly39descendants
  • K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013 · 2 generations on17descendants
  • K132431Thermage CPT SystemSolta Medical, Inc. · 2013 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−10K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−9K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−8K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−7K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−6K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−5K000944Thermage Thermacool SystemThermage, Inc.2000—
−4K013034Modification to: Thermacool IiaThermage, Inc.2001—
−3K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−2K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−1K040135Thermage Thermacool SystemThermage, Inc.2004—
0 (this device)K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009—
+1K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.2010—
+2K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.2010—
+1K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.2011—
+2K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.2013—
+2K132431Thermage CPT SystemSolta Medical, Inc.20131

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199220
199430
199520
199650
199910
200030
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
201350
201520
201630
201740
201830
201910
202010
202120
202240
202350
202480
202590
202660
FIG. 1 — Lineage of K082834, 1995–2026Source: 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
*K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF
Summary page 1
…R 878.4400 Description of the Device 121 CFR 807.92(a)(4)] The subject device is the same device that was authorized for use under 5 10(k) premarket notification K01 3255. The purpose of this submission is to add the indications for use of "non-ablative technique" used for the treatment of mild…
Ellman Intl., Inc.2001—
*K040135Thermage Thermacool System
Summary page 3
…cate Device [21 CFR 807.92(a)(3)1 The predicate devices are as follows: o Ellman Surgitron IEC 120 / 4.0 DU - KO0 3255 o Thermage ThermaCool K040135 The device is identical (materials, technology) to the Surgitron device in K013255. The only difference is the addition of…
Thermage, Inc.2004—

Also cleared against K013255: 5 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053
K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139
K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.201316
K130689Symphony RF GeneratorThermigen, Inc.201311
K122966XP200Btl Industries, Ltd.20131
K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 4, 2012Not classifiedZ-1624-2012Equipment maintenanceEllman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 3 of the 29 ancestors have a recall of any class.
  • Of its descendants, K101967 (Ellman Int'L, Inc., 2010) has gone furthest, with 53 descendants of its own.
  • 5 other devices also cite its predicate K013255.

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. 2009, this device’s year, is highlighted.

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?

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV The device is also indicated for: 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…

Read the full statement (139 words)

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV

The device is also indicated for:

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, epithelidma, 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.

Also cleared against K013255

5 other devices cite the same predicate.

  • K200931RF Surgical GeneratorFulwell, LLC · 2020
  • K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc. · 20131 recall
  • K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040Peak Surgical, Inc. · 2008
  • K061174Surgi-MaxEllman Int'L, Inc. · 2006
  • K051956DR. Oppel ST-501Sometech Incorporated · 2005

More from Ellman Int'L, Inc.

6 FDA decisions under this applicant name. See the company

  • K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc. · 2011
  • K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
  • K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
  • K061174Surgi-MaxEllman Int'L, Inc. · 2006
  • K042710Surgitron Radiolase IIEllman Int'L, Inc. · 2005

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https://510kreport.com/device/K082834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082834: Ellman International Non-Ablative Technique for Surgitron Iec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082834

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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