FDA product code RFE: Laser Cutter
RFE is the FDA product code for laser cutter. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 3 recalls for RFE devices, 3 initiated in the last five years.
Definition
A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment.
Classification
| Field | Value |
|---|---|
| Device name | Laser Cutter |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RFE devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-09-30.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code RFE?
RFE is the FDA product code for laser cutter. It is a Not classified device, reviewed by the Unknown panel.
What device class is RFE?
Not classified.
Have RFE devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code RFE
- Run a recall and safety report across every RFE manufacturer
- Watch product code RFE 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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