510(k) Report

FDA applicant

Lotuxs Medtech (Suzhou) Co., Ltd.

Suzhou Industrial Park, Suzhou, CN2 decisions2021–20230 recalls

FDA records 2 decisions for Lotuxs Medtech (Suzhou) Co., Ltd. (Suzhou Industrial Park, Suzhou, CN) from 2021 to 2023: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PKT (Laser For Disruption Of Adipocyte Cells For…). Its devices cite 2 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 Lotuxs Medtech (Suzhou) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12023: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Lotuxs Medtech (Suzhou) Co., Ltd. by year, 2021–2026Sources: 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 Instrument1decision
  • PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd. · 2023
  • K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd. · 2021

All 2 as Lotuxs Medtech (Suzhou) Co., Ltd. →