510(k) Report

510(k) · Cleared

Cleared

Robi Combi

K930859510(k) TraditionalCleared Feb 28, 1994375-day reviewClass I21 CFR 880.5960

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

Epilady 2000, LLC · LJL Detectors And Removers, Lice, (Including Combs)

Cleared on Feb 28, 1994 after a 375-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 28, 1994
Review
375 days
Class
Class I
Product code
LJL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 2 descendants cleared1990200020102020
  1. This deviceK930859 Robi CombiEpilady 2000, LLC · 1994
  2. Descendant · cites it directly · 1 of its ownK083206 LousebusterLarada Sciences · 2009
  3. Descendant · 2 generations on · 0 of its ownK093144 LousebusterLarada Sciences · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K083206LousebusterLarada Sciences · 2009 · cites it directly1descendant
  • K093144LousebusterLarada Sciences · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930859Robi CombiEpilady 2000, LLC1994—
+1K083206LousebusterLarada Sciences2009—
+2K093144LousebusterLarada Sciences2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
FIG. 1 — Lineage of K930859, 1994–2009Source: 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.

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  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K083206LousebusterLarada Sciences20091

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, K083206 (Larada Sciences, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LJL devices

LJL Detectors And Removers, Lice, (Including Combs): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJL

2in 2017

2009: 22017: 2
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJL

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

Recalls per year · LJL

No recall names LJL since 2007.

Adverse event reports per year · LJL

2in 2024

2018: 12020: 12023: 12024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code LJL, 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
20092—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20172—00
20180—01
20190—00
20200—01
20210—00
20220—00
20230—01
20240—02
20250—00
20260—0—
Cite this page

510(k) Report. “K930859: Robi Combi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930859

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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