510(k) Report

510(k) · Cleared

Cleared

Beamer 1,2,4,6, and 8

K903724510(k) TraditionalCleared Sep 28, 199043-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

Beacon Laboratories, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 28, 1990 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided
Sep 28, 1990
Review
43 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

68 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared2005: 3 descendants cleared2004: 1 descendant cleared2012: 3 descendants cleared2001: 1 descendant cleared2003: 1 descendant cleared2008: 4 descendants cleared2006: 4 descendants cleared2011: 2 descendants cleared2022: 5 descendants cleared2019: 7 descendants cleared2018: 1 descendant cleared2009: 3 descendants cleared2007: 3 descendants cleared2025: 5 descendants cleared2024: 2 descendants cleared2015: 3 descendants cleared2014: 2 descendants cleared2021: 4 descendants cleared2013: 1 descendant cleared2017: 3 descendants cleared2023: 5 descendants cleared2020: 3 descendants cleared1990200020102020
  1. This deviceK903724 Beamer 1,2,4,6, and 8Beacon Laboratories, Inc. · 1990
  2. Descendant · cites it directly · 67 of its ownK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. Descendant · 2 generations on · 30 of its ownK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. Descendant · 2 generations on · 25 of its ownK024047 Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003
  5. Descendant · 2 generations on · 17 of its ownK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
  6. Descendant · 3 generations on · 16 of its ownK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12001: 12003: 12004: 12005: 32006: 42007: 32008: 42009: 32011: 22012: 32013: 12014: 22015: 32017: 32018: 12019: 72020: 32021: 42022: 52023: 52024: 22025: 5
1996high 7 (2019) · low 0 (1997)2026

Most influential descendants

Showing 5 of 68 · See all
  • K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Erbe USA, Inc. · 1996 · cites it directly67descendants
  • K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Erbe USA, Inc. · 2001 · 2 generations on30descendants
  • K024047Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003 · 2 generations on25descendants
  • K030819Plasmajet SystemPlasma Surgical, Ltd. · 2004 · 2 generations on17descendants
  • K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical · 2009 · 3 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903724Beamer 1,2,4,6, and 8Beacon Laboratories, Inc.1990—
+1K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
+2K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
+2K024047Erbe Vio Apc with AccessoriesErbe USA, Inc.2003—
+2K030819Plasmajet SystemPlasma Surgical, Ltd.2004—
+3K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable…Bovie Medical2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
200310
200410
200530
200640
200730
200840
200930
201120
201230
201310
201420
201530
201730
201810
201970
202030
202140
202250
202350
202420
202550
FIG. 1 — Lineage of K903724, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Erbe USA, Inc.199667

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?

  • Of its descendants, K963189 (Erbe USA, Inc., 1996) has gone furthest, with 67 descendants of its own.

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—

More from Beacon Laboratories, Inc.

18 FDA decisions under this applicant name. See the company

  • K930243Flexible ExtenderBeacon Laboratories, Inc. · 1994
  • K930497Argon HandpiecesBeacon Laboratories, Inc. · 1993
  • K925708Disposable Electrosurgery Ball ElectrodeBeacon Laboratories, Inc. · 1993
  • K922289Sesquipolar (TM) Mis ElectrodeBeacon Laboratories, Inc. · 1993
  • K925619Disposable Hand-Switching Esu PencilBeacon Laboratories, Inc. · 1992

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https://510kreport.com/device/K903724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903724: Beamer 1,2,4,6, and 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903724

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026