510(k) Report

FDA applicant

Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

Miami, FL1 decision2024–20240 recalls

FDA records 1 decision for Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (Miami, FL) in 2024: 1 510(k) clearance. All are in product code OAP (Laser, Comb, Hair). Its devices cite 2 predicates, 0 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 Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC by year, 2024–2026Sources: 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, Hair1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 20242cite it

What has FDA decided for it lately?

  • K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024

The one decision as Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC →