510(k) Report

FDA applicant

Lumen Development and Manufacturing, Inc.

Sandy, UT1 decision2007–20070 recalls

FDA records 1 decision for Lumen Development and Manufacturing, Inc. (Sandy, UT) in 2007: 1 510(k) clearance. 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 Lumen Development and Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lumen Development and Manufacturing, 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

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.

  • K072995Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental LaserLumen Development and Manufacturing, Inc. · 20071cites it

What has FDA decided for it lately?

  • K072995Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental LaserLumen Development and Manufacturing, Inc. · 2007

The one decision as Lumen Development and Manufacturing, Inc. →

Other applicant names beginning “Lumen”

FDA records each applicant name separately; these may or may not be the same firm.

Lumen Biomedical, Inc. 5Lumen S.R.L. 1