FDA product code RHK: Laser Marker Or Engraver, Industrial Or Commercial
RHK is the FDA product code for laser marker or engraver, industrial or commercial. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 3 recalls for RHK devices, 3 initiated in the last five years.
Definition
A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam.
Classification
| Field | Value |
|---|---|
| Device name | Laser Marker Or Engraver, Industrial Or Commercial |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RHK devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-04-07.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code RHK?
RHK is the FDA product code for laser marker or engraver, industrial or commercial. It is a Not classified device, reviewed by the Unknown panel.
What device class is RHK?
Not classified.
Have RHK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code RHK
- Run a recall and safety report across every RHK manufacturer
- Watch product code RHK 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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