Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions

Resumo

The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phototherapy device for reducing the appearance of acute post-surgical incisions. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.