510(k) Report

FDA applicant

Jm System Co., Ltd.

Greenwood Village, CO2 decisions2010–20100 recalls

FDA records 2 decisions for Jm System Co., Ltd. (Greenwood Village, CO) in 2010: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 1 predicate, 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 Jm System Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Jm System Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jm System 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

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K100590Edge CO2 Laser SystemJm System Co., Ltd. · 20102cite it

What has FDA decided for it lately?

  • K100590Edge CO2 Laser SystemJm System Co., Ltd. · 2010
  • K100098Plasmalipo/Plasma D30 Lser Surgical DeviceJm System Co., Ltd. · 2010

All 2 as Jm System Co., Ltd. →