510(k) Report

FDA applicant

Polytec Pi, Inc.

Auburn, MA2 decisions1994–19970 recalls

FDA records 2 decisions for Polytec Pi, Inc. (Auburn, MA) from 1994 to 1997: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 predicates, 1 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 Polytec Pi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polytec Pi, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Polytec Pi, Inc. 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 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K942343Laseaway Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 19941cites it
  • K971193Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 19971cites it

What has FDA decided for it lately?

  • K971193Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 1997
  • K942343Laseaway Q-Switched Ruby Laser SystemPolytec Pi, Inc. · 1994

All 2 as Polytec Pi, Inc. →