Although manufacturers may submit drafts of their device labeling, including the label on the immediate container of the device, the submission should be representative of the final version. The directions for use should include a specific statement regarding a clinically significant use of the device and any related warnings, contraindications, or limitations (e. g., precautions or adverse effects).120 The label for a prescription device must bear the following statement: “CAUTION: Federal law restricts this device to sale by or on the
order of a_____________ ,” the blank to be filled with “physician” or another practitioner who
can legally use or order the use of the device.121 In the process of clearing the 510(k) notification, the FDA may change or limit the labeling content, for example, by limiting its statement of a device’s intended uses.
An important component of the 510(k) application is the description of the ‘intended use’ of the device and the labeled ‘indications for use’. The intended use refers to the general functional use of the laser device, such as the effect of the laser radiation on the treatment area. Typically, medical laser devices transfer photon energy to the treatment area, resulting in a local photothermal or a photochemical response. The target site may be the skin surface, or in deeper dermal tissue. The laser parameters (power, pulse width, wavelength, spot-size, fluence) and the target tissue characteristics (body area, pigmentation, vascularity) contribute to the laser-tissue interactions. The tissue response constitutes the intended use of the medical laser devices.
The ‘indications for use’ is more specific, and refers to a specific disease or a condition for the purposes of its treatment, prevention, mitigation, or diagnoses. New indications for use must be supported by reasonable assurance of safety and efficacy for proposed use of the device, as compared with a predicate device. In the 510(k) application, the terms “intended use” and “indications for use” must be used consistently, and reflect the objective intent of the device and intended outcome as compared with the predicate device. It is important to note that if the new device has an indication of use that substantially differs from the predicate device, and the new indication for use results in altering the intended use of the predicate device, then it may have a new intended use. If the intended use for the new device is not the same as the predicate, or if the new device raises new types of safety or effectiveness questions, then the device is considered “Not Substantially Equivalent” (NSE) and must be evaluated through the PMA process.
Specific Indication for use:
For laser devices indicated for hair removal, the FDA has allowed the claim of “permanent reduction” of hair, but not “permanent removal”. The FDA recognizes that laser treatments do not cause permanent hair removal, but can result in a stable reduction in the number of growing hair. So even though the procedure is generally referred to as “laser hair removal” it cannot be claimed to eliminate all hair in the treatment area. The granted claim for the laser hair removal procedures is: “intended to effect stable, long-term, or permanent reduction” of hair. The permanent or stable reduction is further defined as the reduction in hair density that is maintained over a period of time, representing a full hair-growth cycle, after completing a regimen that may include several treatments. Depending on the body site, the hair cycle may vary from four (axilla and bikini-line) to nine months (legs).