510(k) Report

FDA applicant

Beijing Syntech Laser CO., LTD.

Shanghai, CN3 decisions2011–20130 recalls

FDA records 3 decisions for Beijing Syntech Laser CO., LTD. (Shanghai, CN) from 2011 to 2013: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 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 Beijing Syntech Laser CO., LTD.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12012: 12013: 1
2011high 1 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Beijing Syntech Laser CO., LTD. by year, 2011–2026Sources: 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

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K123483Diode LaserBeijing Syntech Laser CO., LTD. · 20136cite it
  • K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 20111cites it
  • K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD. · 20121cites it

What has FDA decided for it lately?

  • K123483Diode LaserBeijing Syntech Laser CO., LTD. · 2013
  • K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD. · 2012
  • K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011

All 3 as Beijing Syntech Laser CO., LTD. →