FDA product code REX: Ir Laser Illuminator Only/Night Vision System
REX is the FDA product code for ir laser illuminator only/night vision system. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 1 recall for REX devices.
Definition
Product, laser, infrared, illuminator only, viewed through night-vision equipment
Classification
| Field | Value |
|---|---|
| Device name | Ir Laser Illuminator Only/Night Vision System |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for REX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-21.
Frequently asked questions
What is FDA product code REX?
REX is the FDA product code for ir laser illuminator only/night vision system. It is a Not classified device, reviewed by the Unknown panel.
What device class is REX?
Not classified.
Have REX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code REX
- Run a recall and safety report across every REX manufacturer
- Watch product code REX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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