FDA 510(k) Intended use statements

FDA 510(k) intended use statements

Below is a list of light-based hair removal devices cleared by FDA. The intended use of each is quoted verbatim from FDA clearances, followed by the date the clearance was issued. Some devices have more than one intended use, because they submitted for additional clearance.

Nd:YAG lasers

Ruby lasers

Alexandrite lasers

Flash lamps

Diode lasers

Source: Releasable 510(k) Database (type in specific 510(k) number to verify intended use)