510(k) Report

510(k) · Cleared

Cleared

System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff

K020408510(k) TraditionalCleared May 2, 200284-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

Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 2, 2002 as substantially equivalent to K001302 (Arthrocare Corp., 2000) and 5 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1994.

Decided
May 2, 2002
Review
84 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K936109 (1994). 14 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestors1999: 1 other ancestor1998: 2 other ancestors1996: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor1986: 1 other ancestor1994: 1 other ancestorK936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 1994K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 19971985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 1 other ancestor K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 1997K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 19940
  1. Root · 3 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 2 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
  3. 1 generation backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  4. This deviceK020408 System 2000 Controller, System 5000 Controller, Footswitch, Power…Arthrocare Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K936109Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc.1994—
−2K960521Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc.1996—
−1K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997—
0 (this device)K020408System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and…Arthrocare Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199110
199410
199520
199610
199820
199910
200020
FIG. 1 — Lineage of K020408, 1994–2002Source: 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? (6)

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
*K001302Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…
Summary page 1
…nical Research February 6, 2002 Visage® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226 === Pa…
Arthrocare Corp.2000—
*K003624Refinity System, Refinity Handpiece and Cable, Refinity Footswitch, Refinity Power Cord…
Summary page 1
…search February 6, 2002 Visage® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226…
Arthrocare Corp.2000—
*K963339Coherent Ultrapulse CO2 Surgical Lasers
Summary page 1
…February 6, 2002 Visage® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226 Product…
Coherent Medical Group1997—
*K980177Sugitron Model: Iec
Summary page 1
…6, 2002 Visage® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226 Product Descrip…
Ellman Intl., Inc.1998—
*K981361Powerstar Bipolar Scissors
Summary page 1
…Visage® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226 Product Description Th…
ETHICON, Inc.1998—
*K991297Uni-Laser 450P CO2 Laser System & Accessories
Summary page 1
…® Wands Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) K001302 K003624 K963339 K980177 K981361 K991297 680 Vaqueros Avenue * Sunnyvale, CA 94085 * (408) 736-0224 * Fax: (408) 736-0226 Product Description The Visage…
Medart Corp.1999—

Also cleared against K001302: 2 other devices →

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 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • None of the 14 ancestors has a recall.
  • 2 other devices also cite its predicate K001302.

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?

The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including:

Abscesses; Oculoplastic Procedures; Aponeurotic Repair; Panniculectomy; Basal Cell Carcinoma; Papilloma Keloids; Biopsy; Pedicle Flap; Blepharoplasty; Rhytidectomy; Cosmetic Repairs; Development of Skin Flaps; Cysts; Skin Tags; Epithelioma; Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows; Keratosis; Mammaplasty; Nevi (Moles); Verrucae (Warts)

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 K001302

2 other devices cite the same predicate.

  • K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  • K012519Arthrocare Electrosurgery WandsArthrocare Corp. · 2001

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K020408 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020408: System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020408

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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