510(k) Report

FDA applicant

Premier North America, Inc.

Fort Lauderdale, FL6 decisions2018–20240 recalls

FDA records 6 decisions for Premier North America, Inc. (Fort Lauderdale, FL) from 2018 to 2024: 6 510(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 53 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 7 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, general and plastic surgery panel, where it files most

How often FDA has decided Premier North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12022: 22023: 22024: 1
2018high 2 (2022) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Premier North America, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Premier North America, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OHSLight Based Over The Counter Wrinkle Reduction3decisions
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision
  • GYBMedia, Electroconductive1decision
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc. · 20232cite it
  • K181659Avologi ENEOPremier North America, Inc. · 20182cite it
  • K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc. · 20221cites it

What has FDA decided for it lately?

  • K233862Nuna Lux (NUNL528)Premier North America, Inc. · 2024
  • K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc. · 2023
  • K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc. · 2023
  • K214100LuminicePremier North America, Inc. · 2022
  • K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc. · 2022
  • K181659Avologi ENEOPremier North America, Inc. · 2018

All 6 as Premier North America, Inc. →