FDA 510(k) Cleared Diode Laser Hair Removal Systems

What is cleared

The clearance covers the Milestone Standard-A and Milestone Smart-M as Class II diode laser hair removal systems for medical use, cleared in 2022 through the FDA 510(k) route. The indication is hair removal and permanent hair reduction for Fitzpatrick skin types I–VI, including tanned skin. The cleared treatment parameters are an 810 nm nominal wavelength, a 10×10 mm spot size and fluence from 1 to 40 J/cm². The systems are standalone prescription-use devices with no network connectivity. Buyers preparing their own market registration can request the clearance documentation pack through the inquiry form.

What the clearance does not cover

The clearance belongs to these two diode models and to the indication above. It does not extend to any other product in the range — not to the alexandrite line, not to the Q-switched Nd:YAG platform, not to the lipolysis, dental or RF devices — and this site never presents it as if it did. It also does not convert marketing language: 'permanent hair reduction' is the cleared indication wording, and it is the wording used across this site wherever the indication is stated. Any supplier who spreads one model's clearance across a whole catalogue is telling you something about their documentation discipline.

Using the clearance in your purchase process

For clinics, the clearance supports the governance file: device identity, indication and parameters in one documented statement. For distributors, it supports the registration conversation in markets that reference FDA clearances. In both cases the practical step is the same — request the documentation pack with your inquiry, name your market, and the reply will state what documentation is available for it.

• Clearance is model-scoped: Standard-A and Smart-M only
• Indication wording is 'permanent hair reduction'
• Documentation pack available through the inquiry form
• No other family in the range carries this clearance