The FDA warns the public to avoid buying laser devices on the internet because those devices may not have proper FDA clearance for sale. For more information about the FDA’s position click here.
MicroLight Corporation of America acknowledges its FDA obligation to monitor the sale of ML830© units through authorized dealers. While complying with FDA rules and regulations, MicroLight may not provide warranty service for ML830© units purchased from unauthorized sources. (ML830© units purchased from authorized dealers enjoy 100% parts and labor warranty [excluding mishandling] for one year after the dealer’s purchase date.)
All MicroLight ML830© laser units are serially numbered when they leave our factory, as required by the FDA, and all ML830© units are sold only under prescription from licensed clinicians, also an FDA requirement. (Prescriptions are required because of the Class IIIb standing of the ML830© unit, as opposed to the Class IIIa designation of the competitors’ lower-power “laser pointer” devices.) MicroLight meets its FDA obligations under the FDA regulations by tracing the marketplace entry and legitimate ownership of all genuine ML830© units.
There are reports that counterfeit or “knockoff” ML830© lasers are offered for sale on the internet. MicroLight urges suspicious or cautious prospective purchasers to contact MicroLight through Contact Us to ensure that those who offer the ML830© are in fact authorized dealers. But, for example, you may be assured that no authorized MicroLight dealer sells the ML830© through eBay, because of the buyer’s need to show a prescription from a licensed clinician at the time of ML830© purchase.
In summary, MicroLight warns prospective purchasers to beware of the situation and protect themselves from unauthorized dealers by avoiding discount sellers, including any that may appear on eBay, because of the risk that the genuine article may not be what is purchased and because of the lack of product warranty that may result from the purchase of an ML830© from any unauthorized person or entity.