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 Dec 16, 2009 as substantially equivalent to K083206 (Larada Sciences, 2009) after a 72-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 16, 2009
- Review
- 72 days
- Class
- Class I
- Product code
- LJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930859 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K083206 | LousebusterSummary page 1…seBuster TM Common Name Louse Eradication System Classification Name Lice Removal Kit §880.5960 5.3 Predicate Device(s) LouseBuster (K083206) 5.5 Device Description The LouseBuster (LB) is a portable, electrically powered, reusable, device that can be… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 15.0 years on median.
- None of the 2 ancestors has a recall.
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 LouseBuster 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 as stated in the FDA summary.
https://510kreport.com/device/K093144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093144: Lousebuster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093144
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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