FDA Approval and Clearance:

There are two types of FDA regulatory processes for medical devices: FDA approval and FDA clearance. FDA approval is used only when a product goes to market through a pre-market approval process (PMA). A PMA or FDA approval is often given for a device that is unique or high risk. The application for approval must have its own clinical trial data. A PMA approval is called "Class 3". It is generally new technology with no legally marketed predicate. A Class 3 approval must have a multicenter-randomized trial and an inspection of the manufacturing site. The second kind of regulatory process is permission to market a device and is called a pre-market notification or 510k. A 510k process gives FDA clearance and is called "Class 2". FDA clearance is not considered a lesser status than FDA approval. Certain devices cannot apply for "approval" because they are considered low risk or because they are similar to other devices already being legally marketed. As more low risk devices companies have applied for FDA clearance, the FDA has begun to ask for clinical trial data for Class 2 devices. FDA clearance includes both safety and efficacy.

In the case of LLLT (low level light therapy):

Thirty to forty low power laser or LED devices have been FDA-cleared for specific uses, such as chronic neck and shoulder pain. Each device is legally approved only for the specific applications for which they are shown to be effective by clinical trials. A device is still considered experimental for any other application. Regulatorily, LLLT devices are compared to IR light-based devices, although they are not thermal. They are classified as non-heating IR lamps. The FDA product codes for LLLT devices are (1) hair growth, (2) non-thermal, and (3) thermal lamps.

Microlight Corporation of America received the first clearance for an LLLT device in 2002. They performed a randomized placebo-controlled study for temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome by the ML830(R) laser. Microlight came in as a PMA because it did not have a predicate, but was changed to a Class 2 because it was not a significant safety risk. The Microlight study showed a relatively small difference between the placebo and device. However, the FDA considered the ML830(R) laser as an alternative to drugs and physical therapy that may work for some people.

Each device is legally marketed for a specific use. 510k's are cleared with an indication for use. A 510k application must give a technical comparison and proof of safety, but not necessarily a randomized placebo controlled trial. If a device is not very similar to one already cleared or if the use is different, a new clinical trial must be performed.

Most LLLT devices have been cleared for the application of pain relief. The FDA cleared the first LLLT device for hair growth in January 2007. The HairMax Laser Comb(R) application supplied a randomized placebo-controlled study. While the study results show a relatively small difference between placebo and the device, the HairMax study demonstrated hair growth at the about same effectiveness as Rogaine. It was decided that a consumer could read the directions and use the device correctly. Furthermore, the FDA decided that a person could select for himself or herself whether they have the specific type of baldness that is indicated for use.

Even if a clinician uses an LLLT device for an FDA-cleared application, an insurance company may decide not to cover the procedure. Regulatorily, these devices are not considered experimental or investigational if used for the specifically approved indication. However, reimbursement is by "standard of care", not just safety and efficacy.

Reference: http://www.pol-us.net/lllt/fda.html