510(k) Report

FDA applicant

Medmix Co., Ltd.

Incheon, KR2 decisions2012–20220 recalls

FDA records 2 decisions for Medmix Co., Ltd. (Incheon, KR) from 2012 to 2022: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 0 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 Medmix Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12022: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Medmix Co., Ltd. by year, 2012–2026Sources: 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 Instrument2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K221083Smartlux MiniMedmix Co., Ltd. · 20222cite it
  • K120460SmartluxMedmix Co., Ltd. · 20122cite it

What has FDA decided for it lately?

  • K221083Smartlux MiniMedmix Co., Ltd. · 2022
  • K120460SmartluxMedmix Co., Ltd. · 2012

All 2 as Medmix Co., Ltd. →