510(k) Report

510(k) · Cleared

Cleared

Coopersurgical Infrared Coagulator

K974168510(k) TraditionalCleared Jan 23, 199879-day reviewClass II21 CFR 876.4300

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

Hogan & Hartson · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Jan 23, 1998 as substantially equivalent to K842810 (Endo Lase, Inc., 1984) and 5 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1984. 109 later devices descend from it.

Decided
Jan 23, 1998
Review
79 days
Class
Class II
Product code
KNS
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K842810 (1984). 6 ancestors in all. 109 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1991: 2 other ancestors1986: 1 other ancestor2006: 1 descendant cleared1999: 1 descendant cleared2011: 4 descendants cleared2007: 1 descendant cleared2017: 7 descendants cleared2014: 3 descendants cleared2020: 11 descendants cleared2023: 7 descendants cleared2016: 10 descendants cleared2018: 5 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2024: 12 descendants cleared2019: 4 descendants cleared2026: 7 descendants cleared2025: 16 descendants cleared2021: 8 descendants cleared2022: 7 descendants clearedK842810 · Infrared Coagulator · Endo Lase, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 9 descendants4 generations forward: 18 descendants5 generations forward: 21 descendants6 generations forward: 17 descendants7 generations forward: 17 descendants8 generations forward: 12 descendants9 generations forward: 5 descendants10 generations forward: 6 descendants K842810 · Infrared Coagulator · Endo Lase, Inc. · 19840+5+10
  1. Root · 1 generation backK842810 Infrared CoagulatorEndo Lase, Inc. · 1984
  2. This deviceK974168 Coopersurgical Infrared CoagulatorHogan & Hartson · 1998
  3. Descendant · cites it directly · 107 of its ownK060069 Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006
  4. Descendant · 2 generations on · 64 of its ownK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
  5. Descendant · 3 generations on · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
  6. Descendant · 2 generations on · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
  7. Descendant · 4 generations on · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013

Showing 5 of 109 descendants. See all descendants

Descendants cleared per year

1999: 12006: 12007: 12011: 42012: 12013: 12014: 32015: 32016: 102017: 72018: 52019: 42020: 112021: 82022: 72023: 72024: 122025: 162026: 7
1999high 16 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 109 · See all
  • K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006 · cites it directly107descendants
  • K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007 · 2 generations on64descendants
  • K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · 3 generations on57descendants
  • K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · 2 generations on56descendants
  • K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · 4 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K842810Infrared CoagulatorEndo Lase, Inc.1984—
0 (this device)K974168Coopersurgical Infrared CoagulatorHogan & Hartson1998—
+1K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc.2006—
+2K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2007—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.2011—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.2011—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199120
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
200710
201140
201210
201310
201430
201530
2016100
201770
201850
201940
2020110
202180
202270
202370
2024120
2025160
202670
FIG. 1 — Lineage of K974168, 1984–2026Source: 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 KNS? 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 KNS device

  1. #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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
*K842810Infrared Coagulator
Summary page 1
…frared Coagulator Common or Usual Name Infrared Coagulator Predicate Devices (1) Redfield Corporation’s Redfield Infrared Coagulator for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648). (2) Laserscope’s KTP/YAG Surgical Laser Systems (K913758)…
Endo Lase, Inc.1984—
*K950836Redfield Infrared Coagulator
Summary page 1
…Name Infrared Coagulator Predicate Devices (1) Redfield Corporation’s Redfield Infrared Coagulator for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648). (2) Laserscope’s KTP/YAG Surgical Laser Systems (K913758) 3) Sharplan Lasers, Inc.’s Model…
Hogan & Hartson1995—
*K911648Redfield Infrared Coagulator
Summary page 1
…te Devices (1) Redfield Corporation’s Redfield Infrared Coagulator for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648). (2) Laserscope’s KTP/YAG Surgical Laser Systems (K913758) 3) Sharplan Lasers, Inc.’s Model 3100 Nd:YAG Surgical Laser (K95116…
Redfield Corp.1991—
*K913758KTP/532 and KTP/Yag
Summary page 1
…agulator for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648). (2) Laserscope’s KTP/YAG Surgical Laser Systems (K913758) 3) Sharplan Lasers, Inc.’s Model 3100 Nd:YAG Surgical Laser (K951165) (4) Xanar Surgical Laser Systems’ Xanar COz Surgical La…
Laserscope1991—
*K951165Sharplan Model 3100 ND:Yag Surgical Laser System
Summary page 1
…tis (K950836), and for tattoo removal (K911648). (2) Laserscope’s KTP/YAG Surgical Laser Systems (K913758) 3) Sharplan Lasers, Inc.’s Model 3100 Nd:YAG Surgical Laser (K951165) (4) Xanar Surgical Laser Systems’ Xanar COz Surgical Laser System Model XAP-15 (K861688). Intended Use The CooperSurgical In…
Sharplan Lasers, Inc.1995—
*K861688Xanar CO2 Surgical Laser System Model Xap-15
Summary page 1
…ystems (K913758) 3) Sharplan Lasers, Inc.’s Model 3100 Nd:YAG Surgical Laser (K951165) (4) Xanar Surgical Laser Systems’ Xanar COz Surgical Laser System Model XAP-15 (K861688). Intended Use The CooperSurgical Infrared Coagulator (‘IRC”) is intended for coagulative necrosis of tissue. It is indicated f…
Xanar, Inc.1986—

What descends from it? (109)

See all 109

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

NumberDeviceApplicantDecidedDescendants
K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc.2006107
K990855Coopersurgical Infrared Coagulator for EntCooperSurgical, Inc.19990

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K060069 (Palomar Medical Technologies, Inc., 2006) has gone furthest, with 107 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007: 12008: 32009: 32010: 42011: 12012: 22013: 22014: 12015: 32016: 32017: 32018: 52019: 72020: 42021: 42022: 32023: 92024: 32025: 112026 (partial year): 2
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2008: 61 days median2009: 212 days median2010: 168 days median2015: 252 days median2016: 30 days median2017: 48 days median2018: 62 days median2019: 66 days median2020: 212 days median2021: 139 days median2022: 182 days median2023: 83 days median2024: 198 days median2025: 171 days median
2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007: 32008: 52009: 22011: 22016: 62017: 12021: 412024: 142026 (partial year): 4
2007high 41 (2021) · low 0 (2010)2026

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

Adverse event reports per year · KNS

1,504in 2025

2007: 1642008: 5872009: 1,0272010: 9082011: 8602012: 8482013: 4492014: 4052015: 4062016: 4572017: 4462018: 5632019: 6682020: 9062021: 8142022: 9132023: 9762024: 1,5332025: 1,504
2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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
20071—3164
20083615587
2009321221,027
201041680908
20111—2860
20122—0848
20132—0449
20141—0405
201532520406
20163306457
20173481446
20185620563
20197660668
202042120906
2021413941814
202231820913
20239830976
20243198141,533
20251117101,504
20262—4—

What is it indicated for?

For the treatment of genital condylomas (condyloma accuminata) and general warts.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Hogan & Hartson

26 FDA decisions under this applicant name. See the company

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  • K942389Trocars, Trocar Sleeves and Reduction SleevesHogan & Hartson · 1996
  • K946215Cardiolipin G Eia Test SystemHogan & Hartson · 1996

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The KNS category page

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https://510kreport.com/device/K974168 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974168: Coopersurgical Infrared Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974168

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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