Lumenis FoLix

FoLix is a Lumenis Be laser system built only for the scalp. It uses a 1565 nm erbium glass fiber laser that delivers non-ablative fractional microbeams. Practical Dermatology reported on June 10, 2024 that it had reached the US market. FDA 510(k) K242349, decided September 9, 2024, clears it for improving the appearance of scalp hair in adult men and women with Fitzpatrick skin types I to IV who are seeking treatment for hair loss.

The 510(k) summary describes the console as a power supply, a laser module with an aiming beam, a control unit and a PC module. Light travels by optical fiber to a handpiece holding a scanner, built from two motor driven mirrors, and a tip that sets the beam focus. A thermoelectric cooler is built into the handpiece. The listed output is up to 70 mJ per microbeam, at up to 500 microbeams per square centimeter.

Its predicate is the F65 Laser System, cleared in June 2023 under K222790, which also took IPL, Nd:YAG and Q-switched handpieces. For FoLix, Lumenis removed those three handpieces and left a single 1565 nm applicator. ResurFX, sold as a module and handpiece for the M22 and Stellar M22 and as a standalone system, uses a 1565 nm erbium glass fiber laser too, but it is cleared for fractional skin resurfacing. A multi handpiece console with a 1565 nm handpiece is therefore an F65, M22 or Stellar M22, not a FoLix.

Because FoLix units are recent, buyers will look closely at the label and paperwork. Send photos of the console serial label and the handpiece label, and of the screen showing the software version. Say whether the tips are complete and undamaged, whether the handpiece cooler and scanner run without errors, and whether Lumenis service records or warranty coverage go with the system.