510(k) Report

FDA applicant

Philips Consumer Lifestyle B.V.

Drachten, NL5 decisions2015–20260 recalls

FDA records 5 decisions for Philips Consumer Lifestyle B.V. (Drachten, NL) from 2015 to 2026: 5 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and NUH (Stimulator, Nerve, Transcutaneous…). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Philips Consumer Lifestyle”.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Philips Consumer Lifestyle B.V.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015: 22025: 22026 (partial year): 1
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Philips Consumer Lifestyle B.V. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Consumer Lifestyle B.V.’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?

  • OHTLight Based Over-The-Counter Hair Removal2decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision
  • GXYElectrode, Cutaneous1decision
  • HGXPump, Breast, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K151035PulseReliefPhilips Consumer Lifestyle · 20157cite it
  • K243453Philips Lumea IPLPhilips Consumer Lifestyle B.V. · 20251cites it

What has FDA decided for it lately?

  • K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips…Philips Consumer Lifestyle B.V. · 2026
  • K253754Philips Lumea IPLPhilips Consumer Lifestyle B.V. · 2025
  • K243453Philips Lumea IPLPhilips Consumer Lifestyle B.V. · 2025
  • K151033Philips Self-Adhesive ElectrodesPhilips Consumer Lifestyle · 2015
  • K151035PulseReliefPhilips Consumer Lifestyle · 2015

All 3 as Philips Consumer Lifestyle B.V. →All 2 as Philips Consumer Lifestyle →