FDA update – April 15 2011

FDA publishes new guidance on Low Level Laser System for Aesthetic Use

The Food and Drug Administration (FDA) has announced the availability of the guidance entitled Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic use. The device is intended to apply low level laser energy to the body to achieve temporary changes in physical appearance.

This guidance document describes and identifies the following issues:

• The classification regulation and product code for the low level laser system for aesthetic use.
• List the risks to health FDA has identified.
• Describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these low level laser systems and lead to a timely 510(k) review.
• Supplements other FDA documents regarding the specific content requirements of a premarket notification submission.
• This guidance document is being immediately implemented as the special control for low level laser systems for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices.

Following the effective date of the final rule, manufacturers of devices within this generic type of device will need to address the issues covered in the special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. These recommendations are in addition to the requirements that low level laser systems must also meet under 21 CFR 1040 and Performance Standards for Light-Emitting Products.

FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low level laser system for aesthetic use.

Therefore, a manufacturer who intends to market a device of this generic type must

• Conform to the general controls of the Federal Food, Drug & Cosmetic Act including the premarket notification requirements described in 21 CFR 807 Subpart E,
• Address the specific risks to health associated with the low level laser system for aesthetic use, including those identified in this guidance, and
• Obtain a substantial equivalence determination from FDA prior to marketing the device.

For more information on this issue you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM251265.pdf or contact mdi at info@mdiconsultants.com  REF: guidance on Low Level Laser.