510(k) Report

FDA applicant

Pulsaderm, LLC

Fort Myers, FL3 decisions2017–20180 recalls

FDA records 3 decisions for Pulsaderm, LLC (Fort Myers, FL) from 2017 to 2018: 3 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OLP (Over-The-Counter Powered Light Based Laser For…). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 4 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2017: 22018: 1
2017high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Pulsaderm, LLC 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?

  • OHSLight Based Over The Counter Wrinkle Reduction1decision
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision
  • OAPLaser, Comb, Hair1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 116 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 133 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 20173cite it
  • K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC · 20171cites it

What has FDA decided for it lately?

  • K182501Hair Laser HeadbandPulsaderm, LLC · 2018
  • K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC · 2017
  • K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017

All 3 as Pulsaderm, LLC →