510(k) Report

510(k) · Cleared

Cleared

Surgitron Radiolase II

K042710510(k) TraditionalCleared Apr 7, 2005189-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 Int'L, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 7, 2005 as substantially equivalent to K992382 (Ellman Intl., Inc., 1999) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1994.

Decided
Apr 7, 2005
Review
189 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K933157 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 1 other ancestorK933157 · Erbotom Icc 200 · Erbe USA, Inc. · 1994K992382 · Surgitron Radiolase · Ellman Intl., Inc. · 19991990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K992382 · Surgitron Radiolase · Ellman Intl., Inc. · 1999K933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19940
  1. Root · 2 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. 1 generation backK992382 Surgitron RadiolaseEllman Intl., Inc. · 1999
  3. This deviceK042710 Surgitron Radiolase IIEllman Int'L, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933157Erbotom Icc 200Erbe USA, Inc.1994—
−1K992382Surgitron RadiolaseEllman Intl., Inc.1999—
0 (this device)K042710Surgitron Radiolase IIEllman Int'L, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
FIG. 1 — Lineage of K042710, 1994–2005Source: 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
*K992382Surgitron Radiolase
Summary page 2
…international, inc.established 1959 5. Identification to predicate devices 5.1I.Sugitron Radiolase with general use indication K992382 3. - 5.2 Surgitron 4.0 Dual RF/120 IEC with general use indicatio…
Ellman Intl., Inc.1999—
*K013225Instaclot for Otc Use, Traumasstat for Prescription Use
Summary page 2
…se with general use indication K992382 3. - 5.2 Surgitron 4.0 Dual RF/120 IEC with general use indication K013225 6. Summary of the technological characteristics of the new device in comparison to the predicate devices.…
Medafor, Inc.2001—

Also cleared against K992382: 1 other device →

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 11 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K992382.

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 preamendment device such as: *Cutting Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures *Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic…

Read the full statement (90 words)

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

*Cutting

Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures

*Blended Cutting and Coagulation

Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures

* Hemostasis

Control of Bleeding, Epilation, Telangicctasia

Bipolar

Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)

Indications for use as stated in the FDA summary.

Also cleared against K992382

1 other device cites the same predicate.

  • K014216Secca SystemCuron Medical, Inc. · 2002

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
  • K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. · 20091 recall
  • K061174Surgi-MaxEllman Int'L, Inc. · 2006

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The GEI category page

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https://510kreport.com/device/K042710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042710: Surgitron Radiolase II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042710

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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