510(k) · Cleared
ClearedLousebuster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Larada Sciences · LJL Detectors And Removers, Lice, (Including Combs)
Cleared on Mar 10, 2009 as substantially equivalent to K930859 (Epilady 2000, LLC, 1994) after a 130-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 10, 2009
- Review
- 130 days
- Class
- Class I
- Product code
- LJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930859 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K093144LousebusterLarada Sciences · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930859 | Robi Combi | Epilady 2000, LLC | 1994 | — |
| 0 (this device) | K083206 | Lousebuster | Larada Sciences | 2009 | — |
| +1 | K093144 | Lousebuster | Larada Sciences | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 LJL? 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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930859 | Robi CombiSummary page 1…Name LouseBustertM Common Name Louse Eradication System Classification Name Lice Removal Kit §880.5960 3 Predicate Device(s) Robi Comb (cleared under K930859) 4 Device Description The LouseBuster (LB) is a portable, electrically powered, reusable, prescription-use device that can… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093144 | Lousebuster | 2009 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K093144 (Larada Sciences, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJL devicesLJL Detectors And Removers, Lice, (Including Combs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LJL
2in 2017
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
MAUDE reports naming product code LJL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LouseBusterTM is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083206: Lousebuster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083206
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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