FAQ™ (302)

The FAQ 302 is a handheld rechargeable device with 20 laser diodes (650±10nm wavelength) and 20 red LED beads (640-660nm) designed to promote hair growth in patients with androgenetic alopecia. It is indicated for males with Hamilton-Norwood Classifications IIa-V and females with Ludwig-Savin Classifications I-II and Fitzpatrick Skin Phototypes I-IV, intended for over-the-counter home use with 8-minute treatments every other day.

The FAQ 302 uses low-level laser diodes and LED light in continuous mode, classified as Class 3R per IEC 60825-1, with <5mW per laser diode. Key differences from predicates: it has 20 laser and 20 LED diodes (versus 26 lasers/30 LEDs or 41 total in predicates), treats approximately 32cm² area, uses an internal rechargeable lithium battery with 90-minute charge time (predicates used power adapter or internal battery), and operates at 8-minute treatment intervals rather than 25 minutes or 3-minute sessions.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin irritation/sensitization), ISO 10993-23 (irritation); IEC 60601-1:2005/AMD1:2012/AMD2:2020 (general safety), IEC 60601-1-6:2010 (usability), IEC 60601-1-11:2015 (home healthcare use), IEC 60601-2-57:2011 (non-laser light source equipment), EN/IEC 60601-1-2:2014/2015 (electromagnetic compatibility), IEC 62366-1:2015 (usability engineering).

The number of light sources, treatment area, wavelength, and intensity are similar to predicate devices and do not raise new safety/effectiveness questions. Although treatment time differs (8 minutes versus 25 minutes or 3 minutes), it remains within the range of predicates and does not create new safety concerns. The power source differs (internal rechargeable battery versus adapter), but the device was tested to applicable electrical safety standards. Biocompatibility, electrical safety, EMC, software validation, cybersecurity, and usability testing all demonstrated adequate performance and risk mitigation, supporting substantial equivalence.