510(k) Report

FDA applicant

Vydence Medical Industria E Comercio Ltda

Ceat - Sao Carlos/Sp Sao Paulo, BR4 decisions2018–20220 recalls

FDA records 4 decisions for Vydence Medical Industria E Comercio Ltda (Ceat - Sao Carlos/Sp Sao Paulo, BR) from 2018 to 2022: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 230 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. 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 Vydence Medical Industria E Comercio Ltda’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12019: 12021: 12022: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Vydence Medical Industria E Comercio Ltda by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 230 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 2 of its 4 were faster than that.

Who builds on its devices?

Later devices cite its devices 2 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.

  • K220041HandPICOVydence Medical Industria E Comercio Ltda · 20221cites it
  • K190007Vydence Laser FamilyVydence Medical Industria E Comercio Ltda · 20191cites it

What has FDA decided for it lately?

  • K220041HandPICOVydence Medical Industria E Comercio Ltda · 2022
  • K202998Vydence Zye and Vydence OneVydence Medical Industria E Comercio Ltda · 2021
  • K190007Vydence Laser FamilyVydence Medical Industria E Comercio Ltda · 2019
  • K171443Etherea MXVydence Medical Industria E Comercio Ltda · 2018

All 4 as Vydence Medical Industria E Comercio Ltda →

Other applicant names beginning “Vydence”

FDA records each applicant name separately; these may or may not be the same firm.

Vydence 1Vydence Medical Industria E Commercio Ltda 1Vydence Medical 1