FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GENERAL AND PLASTIC SURGERY DEVICES; CLASSIFICATION OF THE PHOTOTHERAPY DEVICE FOR REDUCING THE APPEARANCE OF ACUTE POST-SURGICAL INCISIONS

WASHINGTON, May 1 -- Food and Drug Administration has issued a rule called: Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions.

The rule was published in the Federal Register on May 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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...