FDA product code RER: Alignment Laser Product
RER is the FDA product code for alignment laser product. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 4 recalls for RER devices.
Definition
Product, laser, alignment, aid positioning or adjusting parts in relation to each other
Classification
| Field | Value |
|---|---|
| Device name | Alignment Laser Product |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RER devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-11-21.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code RER?
RER is the FDA product code for alignment laser product. It is a Not classified device, reviewed by the Unknown panel.
What device class is RER?
Not classified.
Have RER devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2019-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code RER
- Run a recall and safety report across every RER manufacturer
- Watch product code RER 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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