Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.
Classification. Class II (special controls). The special controls for this device are:
The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.
The cleaning and disinfection instructions for the device must be validated.
The device must be demonstrated to be biocompatible.
Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.
Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.
Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.
Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.
Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal insurance products you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with access to legal services through a network of provider law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our provider law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your provider law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal insurance products, and access to the LegalFix network of provider law firms are subject to the LegalFix Terms of Service and Privacy Policy.
