510(k) Report

FDA applicant

Epilady 2000, LLC

Hazor Haglilit, IL4 decisions1994–20240 recalls

FDA records 4 decisions for Epilady 2000, LLC (Hazor Haglilit, IL) from 1994 to 2024: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LJL (Detectors And Removers, Lice, (Including Combs)). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Epilady 2000, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12022: 12024: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Epilady 2000, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epilady 2000, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions
  • LJLDetectors And Removers, Lice, (Including Combs)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 154 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170970EpilaserEpilady 2000, LLC · 20172cite it
  • K930859Robi CombiEpilady 2000, LLC · 19941cites it
  • K213105Epilaser AbsoluteEpilady 2000, LLC · 20221cites it

What has FDA decided for it lately?

  • K233224Epilaser ProEpilady 2000, LLC · 2024
  • K213105Epilaser AbsoluteEpilady 2000, LLC · 2022
  • K170970EpilaserEpilady 2000, LLC · 2017
  • K930859Robi CombiEpilady 2000, LLC · 1994

All 4 as Epilady 2000, LLC →