FDA product code MYH: System, Non-Coherent Light, Photodynamic Therapy
MYH is the FDA product code for system, non-coherent light, photodynamic therapy. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under MYH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Non-Coherent Light, Photodynamic Therapy |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MYH devices
openFDA lists no recalls for product code MYH.
Frequently asked questions
What is FDA product code MYH?
MYH is the FDA product code for system, non-coherent light, photodynamic therapy. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is MYH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MYH
- Run a recall and safety report across every MYH manufacturer
- Watch product code MYH 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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