FDA product code REK: Research Laser
REK is the FDA product code for research laser. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 5 recalls for REK devices, 1 initiated in the last five years.
Definition
Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.
Classification
| Field | Value |
|---|---|
| Device name | Research Laser |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for REK devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-01-08.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code REK?
REK is the FDA product code for research laser. It is a Not classified device, reviewed by the Unknown panel.
What device class is REK?
Not classified.
Have REK devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2025-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code REK
- Run a recall and safety report across every REK manufacturer
- Watch product code REK 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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