Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
Information
Type
Rule
Regulated products
Medical Devices
Published
April 21, 2014
Last updated
April 21, 2014
Description
Document number 2014-08940. The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)