510(k) Report

FDA applicant

Realton (Suzhou) Medical Technology Co., Ltd.

Suzhou, CN3 decisions2020–20210 recalls

FDA records 3 decisions for Realton (Suzhou) Medical Technology Co., Ltd. (Suzhou, CN) from 2020 to 2021: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Realton (Suzhou) Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2020: 12021: 2
2020high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Realton (Suzhou) Medical Technology Co., Ltd. by year, 2020–2026Sources: 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 Instrument3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 163 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K202828Surgical Green Laser SystemRealton (Suzhou) Medical Technology Co., Ltd. · 2021
  • K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd. · 2021
  • K202601Single-use Sterile medical laser fiberRealton (Suzhou) Medical Technology Co., Ltd. · 2020

All 3 as Realton (Suzhou) Medical Technology Co., Ltd. →