510(k) Report

FDA applicant

Nutra Luxe MD, LLC

Fort Myers, FL9 decisions2014–20160 recalls

FDA records 9 decisions for Nutra Luxe MD, LLC (Fort Myers, FL) from 2014 to 2016: 9 510(k) clearances. Most are in product codes OLP (Over-The-Counter Powered Light Based Laser For…) and OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 17 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 Nutra Luxe MD, LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2016

2014: 22015: 32016: 4
2014high 4 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Nutra Luxe MD, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nutra Luxe MD, 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?

  • OLPOver-The-Counter Powered Light Based Laser For Acne4decisions
  • OAPLaser, Comb, Hair3decisions
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K141308Nutra Light RedNutra Luxe MD, LLC · 20145cite it
  • K132838Nutra Light BlueNutra Luxe MD, LLC · 20142cite it
  • K141596Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 20151cites it
  • K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC · 20161cites it
  • K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC · 20161cites it
  • K141588Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 20151cites it

What has FDA decided for it lately?

  • K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC · 2016
  • K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC · 2016
  • K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC · 2016
  • K150826Nutra Face Lift Model PE8050Nutra Luxe MD, LLC · 2016
  • K150370Nutra Light AdvancedNutra Luxe MD, LLC · 2015
  • K141596Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 2015
  • K141588Nutra Stim Hair Laser CombNutra Luxe MD, LLC · 2015
  • K141308Nutra Light RedNutra Luxe MD, LLC · 2014

All 9 as Nutra Luxe MD, LLC →