FDA applicant

Theralase, Inc.

Markham, Ontario, CA2 decisions2005–20157 recalls

FDA records 2 decisions for Theralase, Inc. (Markham, Ontario, CA) from 2005 to 2015: 2 510(k) clearances. All are in product code NHN (Powered Light Based Laser Non-Thermal…). 7 recalls are 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 Theralase, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2019

2007high 7 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Theralase, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Theralase, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?