FDA product code RDW: General Purpose Laser Products
RDW is the FDA product code for general purpose laser products. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 5 recalls for RDW devices, 4 initiated in the last five years.
Definition
Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use.
Classification
| Field | Value |
|---|---|
| Device name | General Purpose Laser Products |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RDW devices
5 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-04-15.
| Year | Recalls |
|---|---|
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code RDW?
RDW is the FDA product code for general purpose laser products. It is a Not classified device, reviewed by the Unknown panel.
What device class is RDW?
Not classified.
Have RDW devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2026-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code RDW
- Run a recall and safety report across every RDW manufacturer
- Watch product code RDW 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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