510(k) Report

FDA applicant

Lase, Inc.

Washington, DC3 decisions1987–19930 recalls

FDA records 3 decisions for Lase, Inc. (Washington, DC) from 1987 to 1993: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). 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 Lase, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lase, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lase, 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 Instrument1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision
  • FYDApparatus, Exhaust, Surgical1decision

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.

  • K922555Enviromate (TM) Smoke Evacuation SystemLase, Inc. · 19931cites it

What has FDA decided for it lately?

  • K922555Enviromate (TM) Smoke Evacuation SystemLase, Inc. · 1993
  • K874157Lase Evacuator/AspiratorLase, Inc. · 1988
  • K871334Lase System IILase, Inc. · 1987

All 3 as Lase, Inc. →