510(k) Report

FDA applicant

Leana Orders, Inc.

Staten Island, NY2 decisions2017–20210 recalls

FDA records 2 decisions for Leana Orders, Inc. (Staten Island, NY) from 2017 to 2021: 2 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Its devices cite 3 predicates, 1 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, physical medicine panel, where it files most

How often FDA has decided Leana Orders, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12021: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Leana Orders, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OAPLaser, Comb, Hair2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K171895Grivamax Hair Growth SystemLeana Orders, Inc. · 20172cite it

What has FDA decided for it lately?

  • K211192Grivamax Family of Lasers, Models 272 and 148Leana Orders, Inc. · 2021
  • K171895Grivamax Hair Growth SystemLeana Orders, Inc. · 2017

All 2 as Leana Orders, Inc. →