§ 886.5201 Intense pulsed light device for managing dry eye.

(a) Identification. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must evaluate adverse events and improvement of dry eye signs and symptoms under anticipated conditions of use. (2) Thermal safety assessment in a worst-case scenario must be performed to validate temperature safeguards. (3) Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Physician and patient labeling must include: (i) Device technical parameters; (ii) A summary of the clinical performance testing conducted with the device; (iii) A description of the intended treatment area location; (iv) Warnings and instructions regarding the use of safety-protective eyewear for patient and device operator; (v) A description of intense pulse light (IPL) radiation hazards and protection for patient and operator; (vi) Instructions for use, including an explanation of all user interface components; and (vii) Instructions on how to clean and maintain the device and its components.