§ 878.4880 Phototherapy device for reducing the appearance of acute post-surgical incisions.

(a) Identification. This device consists of a light-emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following: (i) Verification and validation testing of the spectrum and power intensity of the light source; (ii) Heat dissipation from the area following device application; and (iii) Biophotonic properties of the photoconverter gel, including radiant fluence (transmitted light and fluorescence) delivered through the photoconverter gel by the device. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must evaluate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the photoconverter gel by demonstrating continued sterility and functional performance over the identified shelf life. (5) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device in the intended use environment. (6) Software verification, validation, and hazard analysis must be performed for any software components. (7) Labeling must include the following: (i) A summary of the device technical specifications, including light wavelength, irradiance, and application area; (ii) Warnings for ensuring eye safety, including use of protective eyeglasses used for both the operator and the patient; and (iii) A shelf life for the photoconverter gel.