FDA applicant

Lakong Medical Devices Co., Ltd.

Dongguan, CN2 decisions2026–20260 recalls

FDA records 2 decisions for Lakong Medical Devices Co., Ltd. (Dongguan, CN) in 2026: 2 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and SJH (Portable Dental Operative Unit). 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, dental panel, where it files most

How often FDA has decided Lakong Medical Devices Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Lakong Medical Devices Co., Ltd. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lakong Medical Devices Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Lakong”

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

Lakong Medical Device Company, Ltd. 1

Lakong Medical Devices Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lakong”