510(k) Report

FDA applicant

Jiangsu Unimed Laser Technology Co., Ltd.

Jiangyin, CN1 decision2018–20180 recalls

FDA records 1 decision for Jiangsu Unimed Laser Technology Co., Ltd. (Jiangyin, CN) in 2018: 1 510(k) clearance. All are in product code ONG (Powered Laser Surgical Instrument With…). 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 Jiangsu Unimed Laser Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Jiangsu Unimed Laser Technology Co., Ltd. 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?

  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

What has FDA decided for it lately?

  • K182498Advanced Skin Renewing DeviceJiangsu Unimed Laser Technology Co., Ltd. · 2018

The one decision as Jiangsu Unimed Laser Technology Co., Ltd. →