510(k) Report

510(k) · Cleared

Cleared

Cooper Laser Sonics Cusa Model 200

K853143510(k) TraditionalCleared Oct 16, 198579-day reviewClass U

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

Cooper Lasersonics, Inc. · LBK Neurosurgical Ultrasonic Instruments

Cleared on Oct 16, 1985 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Oct 16, 1985
Review
79 days
Class
Class U
Product code
LBK
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK853143 Cooper Laser Sonics Cusa Model 200Cooper Lasersonics, Inc. · 1985
  2. Descendant · cites it directly · 6 of its ownK990572 SonotomeSonokinetics, Inc. · 1999
  3. Descendant · 2 generations on · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
  4. Descendant · 3 generations on · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
  5. Descendant · 4 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
  6. Descendant · 5 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 22016: 12017: 12018: 12020: 12023: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K990572SonotomeSonokinetics, Inc. · 1999 · cites it directly6descendants
  • K152699Apollo SystemPenumbra, Inc. · 2016 · 2 generations on4descendants
  • K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · 3 generations on2descendants
  • K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 4 generations on1descendant
  • K230125Neuroblade SystemClearmind Biomedical · 2023 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853143Cooper Laser Sonics Cusa Model 200Cooper Lasersonics, Inc.1985—
+1K990572SonotomeSonokinetics, Inc.1999—
+2K152699Apollo SystemPenumbra, Inc.2016—
+3K171332Artemis Neuro Evacuation DevicePenumbra, Inc.2017—
+4K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical2020—
+5K230125Neuroblade SystemClearmind Biomedical2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
201610
201710
201810
202010
202310
FIG. 1 — Lineage of K853143, 1985–2023Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (7)

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

NumberDeviceApplicantDecidedDescendants
K990572SonotomeSonokinetics, Inc.19996
K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990

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, K990572 (Sonokinetics, Inc., 1999) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LBK devices

LBK Neurosurgical Ultrasonic Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBK

FDA has decided no LBK device since 2007.

Median 510(k) review, days · LBK

Too few LBK 510(k)s in any year since 2007 to give a median.

Recalls per year · LBK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LBK

2in 2025

2007: 32008: 12012: 42013: 162014: 92019: 42025: 2
2007high 16 (2013) · low 0 (2009)2025

MAUDE reports naming product code LBK, 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
20070—03
20080—01
20090—00
20100—00
20110—00
20120—04
20130—116
20140—09
20150—00
20160—00
20170—00
20180—00
20190—04
20200—00
20210—00
20220—00
20230—00
20240—00
20250—02
20260—0—

More from Cooper Lasersonics, Inc.

54 FDA decisions under this applicant name. See the company

  • K880427Illumina 40 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K880429Illumina 55 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K880807Illumina Model 25 CO2 Laser for General/Plastic SUCooper Lasersonics, Inc. · 1988
  • K880428Illumina 25 CO2 Laser SystemCooper Lasersonics, Inc. · 1988
  • K880808Illumina Model 40 CO2 Laser for General/Plastic SUCooper Lasersonics, Inc. · 1988

Recent decisions in LBK

The LBK category page

  • K972612Dissectron Portable UnitSatelec · 1997
  • K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
  • K884413Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
  • K884412Cusa System 200C,T & M Ultrasonic Surgical Aspira.Valleylab, Inc. · 1988
  • K883522Amerimed Ultrasonic Surgical Aspiration KitAmerimed US Corp. · 1988

https://510kreport.com/device/K853143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K853143: Cooper Laser Sonics Cusa Model 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853143

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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