ILY vs. NHN specifications

h1. The FDA Mystery of “NHN” vs. “ILY” Claims

(Solving the mystery. By Fred A. Simpson, Esq., Executive V. P., MicroLight Corporation of America)

The FDA controls radiation-emitting medical devices to protect the public. The FDA does this by “clearing” such devices for specific “indications for use” only after device manufacturers prove their devices are safe and effective.

The FDA uses a set of product codes (“procodes”) to classify LED and laser devices for review and clearance. One of those codes is “ILY.” Another is “NHN.” Why does the FDA use these codes, and what are the differences between them?

The FDA explains that it designates a device “ILY” only if the following is true:

For devices requesting clearance for indications under the ILY procode, that is, devices that use thermal energy to provide pain relief through local heating, we [at the FDA] require that these devices demonstrate the ability to generate temperatures of 40-42o C at the treatment site for a duration of 5-10 minutes.

From these criteria and the ILY title “Infrared Lamp” it is clear that ILY devices treat pain with heat, the same way as electric heating pads, hot packs or sunlamps.

When the MicroLight ML830® was cleared, the FDA added a new code, “NHN,” and its title is “Lamp, Non-Heating, For Adjunctive Use In Pain Therapy.”

The new FDA “NHN” code implies that NHN devices treat pain by means other than the mere topical heating of tissue, and studies show this to be true. The new treatment is with true laser diodes (which are “NHN”) as opposed to light emitting diodes or LED’s (which are “ILY”).

Who sells ILY devices?

U.S. Laser Anodyne
MedX Spectrum
Avicenna Dynatronics
Thor Chattanooga