FDA product code RGA: Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product
RGA is the FDA product code for product incorporating certified class 1 data utility/peripheral laser product. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 2 recalls for RGA devices, 2 initiated in the last five years.
Definition
A utility/peripheral laser product that incorporates a certified class 1 laser.
Classification
| Field | Value |
|---|---|
| Device name | Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RGA devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-04-17.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code RGA?
RGA is the FDA product code for product incorporating certified class 1 data utility/peripheral laser product. It is a Not classified device, reviewed by the Unknown panel.
What device class is RGA?
Not classified.
Have RGA devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-04-17.
Next steps
- Run an FDA pathway report with predicate devices for product code RGA
- Run a recall and safety report across every RGA manufacturer
- Watch product code RGA 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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