510(k) Report

FDA applicant

Neauvia North America

Raliegh, NC6 decisions2020–20230 recalls

FDA records 6 decisions for Neauvia North America (Raliegh, NC) from 2020 to 2023: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neauvia North America, Inc.”.

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 Neauvia North America’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 12021: 22022: 12023: 2
2020high 2 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Neauvia North America by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neauvia North America’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • PBXMassager, Vacuum, Radio Frequency Induced Heat1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 173 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 126 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K192813Plasma IQNeauvia North America, Inc. · 20203cite it
  • K212329Plasma IQNeauvia North America, Inc. · 20212cite it
  • K230077LaserMENeauvia North America · 20231cites it
  • K223222Plasma IQNeauvia North America, Inc. · 20231cites it
  • K202780SectumNeauvia North America · 20211cites it

What has FDA decided for it lately?

  • K230077LaserMENeauvia North America · 2023
  • K223222Plasma IQNeauvia North America, Inc. · 2023
  • K213261EpilMENeauvia North America · 2022
  • K212329Plasma IQNeauvia North America, Inc. · 2021
  • K202780SectumNeauvia North America · 2021
  • K192813Plasma IQNeauvia North America, Inc. · 2020

All 3 as Neauvia North America →All 3 as Neauvia North America, Inc. →