510(k) Report

510(k) · Cleared

Cleared

Iridex Wireless Footswitch

K062074510(k) TraditionalCleared Nov 14, 2006116-day reviewClass II21 CFR 886.4390

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

Iridex Corp · HQF Laser, Ophthalmic

Cleared on Nov 14, 2006 as substantially equivalent to K020374 (Iridex Corp, 2002) and 7 other predicates after a 116-day review. Its family tree reaches back 9 generations to 1993.

Decided
Nov 14, 2006
Review
116 days
Class
Class II
Product code
HQF
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K931783 (1993). 54 ancestors in all, the oldest K883541 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 4 other ancestors2004: 1 other ancestor2003: 3 other ancestors2002: 4 other ancestors1997: 3 other ancestors2001: 4 other ancestors2000: 3 other ancestors1999: 3 other ancestors1998: 2 other ancestors1996: 4 other ancestors1995: 2 other ancestors1991: 5 other ancestors1990: 1 other ancestor1989: 3 other ancestors1988: 1 other ancestor1994: 2 other ancestorsK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K990691 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1999K991444 · Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). · Computer Motion, Inc. · 1999K022393 · Merdoc System · Stryker Endoscopy · 2003K033135 · Stryker Wireless Universal Footswitch System · Stryker Endoscopy · 2004K053510 · IR Wireless Foot Switch · Linemaster Switch Corp. · 2006 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 25 other ancestors3 generations back: 9 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor7 generations back: 1 other ancestor K053510 · IR Wireless Foot Switch · Linemaster Switch Corp. · 2006 · recalledK033135 · Stryker Wireless Universal Footswitch System · Stryker Endoscopy · 2004K022393 · Merdoc System · Stryker Endoscopy · 2003K991444 · Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). · Computer Motion, Inc. · 1999K990691 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1999K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993−50
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 5 generations between
  3. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  4. 2 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
  5. 1 generation backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
  6. This deviceK062074 Iridex Wireless FootswitchIridex Corp · 2006
Show all 9 generations
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
  6. 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
  7. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  8. 2 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
  9. 1 generation backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
  10. This deviceK062074 Iridex Wireless FootswitchIridex Corp · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−8K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−7K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−6K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−5K990691Hermes Operating Room Control CenterComputer Motion, Inc.1999—
−4K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc.1999—
−3K022393Merdoc SystemStryker Endoscopy2003—
−2K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy2004—
−1K053510IR Wireless Foot SwitchLinemaster Switch Corp.20062
0 (this device)K062074Iridex Wireless FootswitchIridex Corp2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198930
199010
199150
199420
199520
199640
199730
199820
199930
200030
200140
200240
200330
200410
200540
FIG. 1 — Lineage of K062074, 1993–2006Source: 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), 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 HQF? 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 HQF device

  1. #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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? (10)

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
*K020374Oculight SL/SLX
Summary page 1
…Lasers, Ophthalmic II. Predicate Devices IRIDEX Standard Footswitch - Accessory for: * IRIS Medical OcuLight SL/SLx Laser System (K020374) * IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) * IRIDEX DioLite Laser System (K964074)…
Iridex Corp2002—
*K031665Iris Medical Oculight GL/GLX Laser Systems
Summary page 1
…IRIDEX Standard Footswitch - Accessory for: * IRIS Medical OcuLight SL/SLx Laser System (K020374) * IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) * IRIDEX DioLite Laser System (K964074) * IRIDEX VariLite Laser System (K041930) Ivoclar Viv…
Iridex Corp2003—
*K050562Oculight GL/GLX
Summary page 1
…IRIDEX Standard Footswitch - Accessory for: * IRIS Medical OcuLight SL/SLx Laser System (K020374) * IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) * IRIDEX DioLite Laser System (K964074) * IRIDEX VariLite Laser System (K041930) Ivoclar Vivadent Ody…
Iridex Corp2005—
*K964074Diolite 532
Summary page 1
…* IRIS Medical OcuLight SL/SLx Laser System (K020374) * IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) * IRIDEX DioLite Laser System (K964074) * IRIDEX VariLite Laser System (K041930) Ivoclar Vivadent Odyssey 2.4G Pedal - Accessory for: * Odyss…
Iriderm Div.1997—
*K041930Varilite Laser System
Summary page 1
…020374) * IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) * IRIDEX DioLite Laser System (K964074) * IRIDEX VariLite Laser System (K041930) Ivoclar Vivadent Odyssey 2.4G Pedal - Accessory for: * Odyssey 2.4G Diode Laser (K050453) Stryker Wir…
Iridex Corporation2004—
*K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050
Summary page 1
…ser System (K964074) * IRIDEX VariLite Laser System (K041930) Ivoclar Vivadent Odyssey 2.4G Pedal - Accessory for: * Odyssey 2.4G Diode Laser (K050453) Stryker Wireless Universal Footswitch (K033135) Linemaster IR Wireless Footswitch ( K0535 10) IV. Product…
Ivoclar Vivadent, Inc.2005—
*K033135Stryker Wireless Universal Footswitch System
Summary page 1
…tem (K041930) Ivoclar Vivadent Odyssey 2.4G Pedal - Accessory for: * Odyssey 2.4G Diode Laser (K050453) Stryker Wireless Universal Footswitch (K033135) Linemaster IR Wireless Footswitch ( K0535 10) IV. Product Description The Wireless Footswitch is an alte…
Stryker Endoscopy2004—
*K053510IR Wireless Foot Switch
Summary page 1
…edal - Accessory for: * Odyssey 2.4G Diode Laser (K050453) Stryker Wireless Universal Footswitch (K033135) Linemaster IR Wireless Footswitch ( K0535 10) IV. Product Description The Wireless Footswitch is an alternate option to the existing cabled footswitch for user…
Linemaster Switch Corp.20062
*—IRIDEX Standard Footswitch
Named without a submission number
—
*—Ivoclar Vivadent Odyssey 2.4G Pedal
Named without a submission number
—

Also cleared against K020374: 8 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 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 7 of the 54 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K020374.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQF

3in 2025

2007: 42008: 32009: 72010: 22011: 42012: 52013: 62014: 32015: 42016: 32017: 32018: 12019: 42020: 42021: 12022: 72023: 52024: 32025: 32026 (partial year): 2
2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007: 198 days median2008: 28 days median2009: 115 days median2011: 128 days median2012: 179 days median2013: 225 days median2014: 215 days median2015: 295 days median2016: 271 days median2017: 189 days median2019: 107 days median2020: 53 days median2022: 86 days median2023: 155 days median2024: 167 days median2025: 264 days median
2007high 295 (2015) · low 28 (2008)2026

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

Recalls per year · HQF

1in 2025

2007: 22008: 12009: 22010: 32011: 52012: 12013: 22014: 42025: 1
2007high 5 (2011) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQF

106in 2025

2007: 602008: 342009: 332010: 432011: 262012: 412013: 392014: 582015: 802016: 1082017: 772018: 822019: 662020: 722021: 1002022: 1112023: 922024: 752025: 106
2007high 111 (2022) · low 26 (2011)2025

MAUDE reports naming product code HQF, 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
20074198260
2008328134
20097115233
20102—343
20114128526
20125179141
20136225239
20143215458
20154295080
201632710108
20173189077
20181—082
20194107066
2020453072
20211—0100
20227860111
20235155092
20243167075
202532641106
20262—0—

What is it indicated for?

The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.

The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached

Indications for use as stated in the FDA summary.

Also cleared against K020374

8 other devices cite the same predicate.

  • K202760Iridex 810 LaserIridex Corporation · 2020
  • K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
  • K040209Iris Medical IQ 810 PhotocoagulatorIridex Corp · 2004
  • K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
  • K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
  • K023464Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003

More from Iridex Corp

13 FDA decisions under this applicant name. See the company

  • K121475Txcell Scanning Laser Delivery SystemIridex Corp · 2012
  • K071687Famili of Iridex IQ Laser SystemsIridex Corp · 2008
  • K062369Iridex Oculight TXIridex Corp · 2006
  • K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006
  • K050562Oculight GL/GLXIridex Corp · 2005

Recent decisions in HQF

The HQF category page

  • K252979Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
  • K251507Integre LioQuantel Medical · 2026
  • K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
  • K243014EyeQ nanoECPEyeq, Inc. · 2025
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 20251 recall

https://510kreport.com/device/K062074 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062074: Iridex Wireless Footswitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062074

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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