510(k) Report

510(k) · Cleared

Cleared

Compu-Blend Epilator

K954031510(k) TraditionalCleared Jan 5, 1996130-day reviewClass I21 CFR 878.5350

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

R. A. Fischer Co. Corp. · KCW Epilator, High Frequency, Needle-Type

Cleared on Jan 5, 1996 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 751 later devices descend from it.

Decided
Jan 5, 1996
Review
130 days
Class
Class I
Product code
KCW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2003: 6 descendants cleared2004: 2 descendants cleared2005: 4 descendants cleared2012: 17 descendants cleared2008: 17 descendants cleared2006: 5 descendants cleared2009: 18 descendants cleared2007: 9 descendants cleared2010: 21 descendants cleared2019: 29 descendants cleared2013: 24 descendants cleared2011: 14 descendants cleared2023: 49 descendants cleared2015: 28 descendants cleared2020: 44 descendants cleared2017: 40 descendants cleared2018: 34 descendants cleared2016: 43 descendants cleared2022: 55 descendants cleared2024: 78 descendants cleared2014: 30 descendants cleared2025: 90 descendants cleared2026: 55 descendants cleared2021: 38 descendants cleared1995200020052010201520202025
  1. This deviceK954031 Compu-Blend EpilatorR. A. Fischer Co. Corp. · 1996
  2. Descendant · cites it directly · 750 of its ownK021149 Aurora DSSyneron Medical, Ltd. · 2002
  3. Descendant · 2 generations on · 681 of its ownK024064 Polaris DSSyneron Medical, Ltd. · 2003
  4. Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
  5. Descendant · 4 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
  6. Descendant · 5 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005

Showing 5 of 751 descendants. See all descendants

Descendants cleared per year

2002: 12003: 62004: 22005: 42006: 52007: 92008: 172009: 182010: 212011: 142012: 172013: 242014: 302015: 282016: 432017: 402018: 342019: 292020: 442021: 382022: 552023: 492024: 782025: 902026: 55
2002high 90 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 751 · See all
  • K021149Aurora DSSyneron Medical, Ltd. · 2002 · cites it directly750descendants
  • K024064Polaris DSSyneron Medical, Ltd. · 2003 · 2 generations on681descendants
  • K030186Polris LVSyneron Medical, Ltd. · 2003 · 3 generations on680descendants
  • K031671Polaris WRSyneron Medical, Ltd. · 2003 · 4 generations on678descendants
  • K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 5 generations on476descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954031Compu-Blend EpilatorR. A. Fischer Co. Corp.1996—
+1K021149Aurora DSSyneron Medical, Ltd.2002—
+2K024064Polaris DSSyneron Medical, Ltd.2003—
+3K030186Polris LVSyneron Medical, Ltd.2003—
+4K031671Polaris WRSyneron Medical, Ltd.2003—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200360
200420
200540
200650
200790
2008170
2009180
2010210
2011140
2012170
2013240
2014300
2015280
2016430
2017400
2018340
2019290
2020440
2021380
2022550
2023490
2024780
2025900
2026550
FIG. 1 — Lineage of K954031, 1996–2026Source: 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 KCW? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (751)

See all 751

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

NumberDeviceApplicantDecidedDescendants
K021149Aurora DSSyneron Medical, Ltd.2002750

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, K021149 (Syneron Medical, Ltd., 2002) has gone furthest, with 750 descendants of its own.

How does its category compare?

All KCW devices

KCW Epilator, High Frequency, Needle-Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCW

FDA has decided no KCW device since 2007.

Median 510(k) review, days · KCW

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

Recalls per year · KCW

No recall names KCW since 2007.

Adverse event reports per year · KCW

2in 2020

2014: 12015: 12020: 2
2007high 2 (2020) · low 0 (2007)2025

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

More from R. A. Fischer Co. Corp.

13 FDA decisions under this applicant name. See the company

  • K964208MD-1A Galvanic UnitR. A. Fischer Co. Corp. · 1997
  • K895365MD-2 Iontophoresis UnitR. A. Fischer Co. Corp. · 1990
  • K893389Model SE-5 EpilatorR. A. Fischer Co. Corp. · 1989
  • K884079Model CBX EpilatorR. A. Fischer Co. Corp. · 1988
  • K871372CB-7 Electronic EpilatorR. A. Fischer Co. Corp. · 1987

Recent decisions in KCW

The KCW category page

  • K952611Sterex Sterile Disposale Electrolysis Needle for Use in EpilationSterex Electrolysis Intl., Ltd. · 1995
  • K945192Hair Removal SystemL.P. Systems Corp. · 1995
  • K943928Apilus ElectropilDectro Intl., Inc. · 1995
  • K943398The Blendtone RoyaleInstantron · 1994
  • K943399THE SS-99Instantron · 1994

https://510kreport.com/device/K954031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954031: Compu-Blend Epilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954031

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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