510(k) Report

FDA applicant

2035, Inc.

Littleton, CO1 decision2009–20090 recalls

FDA records 1 decision for 2035, Inc. (Littleton, CO) in 2009: 1 510(k) clearance. All are in product code NHN (Powered Light Based Laser Non-Thermal…). 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, physical medicine panel, where it files most

How often FDA has decided 2035, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — 2035, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 2035, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive…1decision

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.

  • K080513Qlaser System2035, Inc. · 20091cites it

What has FDA decided for it lately?

  • K080513Qlaser System2035, Inc. · 2009

The one decision as 2035, Inc. →