A term used for procedures that are legal, but are not specifically approved for a particular device or drug. An example is Lasik. The excimer laser is FDA approved for PRK, but not for Lasik, which is a combination of ALK and PRK. The Lasik procedure comes under the definition of the practise of medicine (also called scope of practice), so the FDA does not necessarily need to approve the use of the excimer laser specifically for Lasik. An easier example is the scalpel. The scalpel is not specifically approved for all procedures that may require a scalpel, but if a medical doctor determines the use of this FDA approved tool is appropriate, then it is okay with the FDA. Some excimer lasers have received FDA approval specifically for Lasik, but this is more for marketing purposes than to accommodate any legal requirement.