FDA product code RFK: Laser Vision
RFK is the FDA product code for laser vision. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 1 recall for RFK devices.
Definition
A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment. Often incorporated in an automated assembly line system.
Classification
| Field | Value |
|---|---|
| Device name | Laser Vision |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RFK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-04-15.
Frequently asked questions
What is FDA product code RFK?
RFK is the FDA product code for laser vision. It is a Not classified device, reviewed by the Unknown panel.
What device class is RFK?
Not classified.
Have RFK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code RFK
- Run a recall and safety report across every RFK manufacturer
- Watch product code RFK 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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