510(k) Report

FDA applicant

Max Engineering, Ltd.

North Reading, MA2 decisions2003–20050 recalls

FDA records 2 decisions for Max Engineering, Ltd. (North Reading, MA) from 2003 to 2005: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 7 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 Max Engineering, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Max Engineering, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Max Engineering, Ltd. by year, 2007–2026Sources: 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 Instrument2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd. · 2005
  • K032735Spectra QT: Q-Switched ND: Yag Laser SystemMax Engineering, Ltd. · 2003

All 2 as Max Engineering, Ltd. →