510(k) Report

FDA applicant

China Daheng Group, Inc.

Shanghai, China, CN2 decisions2010–20110 recalls

FDA records 2 decisions for China Daheng Group, Inc. (Shanghai, China, CN) from 2010 to 2011: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 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 China Daheng Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — China Daheng Group, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like China Daheng Group, Inc.’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

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K113212Dental Laser Therapy SystemChina Daheng Group, Inc. · 20111cites it
  • K102669Diode Laser Therapy SystemChina Daheng Group, Inc. · 20101cites it

What has FDA decided for it lately?

  • K113212Dental Laser Therapy SystemChina Daheng Group, Inc. · 2011
  • K102669Diode Laser Therapy SystemChina Daheng Group, Inc. · 2010

All 2 as China Daheng Group, Inc. →