510(k) Report

FDA applicant

Lihtan Technologies, Inc.

Mountain View, CA2 decisions1990–19940 recalls

FDA records 2 decisions for Lihtan Technologies, Inc. (Mountain View, CA) from 1990 to 1994: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Lihtan Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lihtan Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lihtan Technologies, 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

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.

  • K901008Hexascan HandpieceLihtan Technologies, Inc. · 19902cite it

What has FDA decided for it lately?

  • K942729Lihtan 4100 KryptonLihtan Technologies, Inc. · 1994
  • K901008Hexascan HandpieceLihtan Technologies, Inc. · 1990

All 2 as Lihtan Technologies, Inc. →