CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

The CurrentBody Skin Dual Light Hair Growth Helmet (model MZ-07A) is an over-the-counter device designed to promote hair growth in males with Norwood-Hamilton classifications IIa-V or females with Ludwig-Savin classifications I-II, both with Fitzpatrick skin types I-IV. The helmet contains 100 laser diodes (655±5nm) and 200 red light diodes (660±5nm) that emit visible red light for 20-minute daily treatment sessions.

The device contains 100 laser diodes at 655±5nm wavelength and 200 LED diodes at 660±5nm wavelength, compared to the predicate's 100 laser diodes at 655nm and 200 LEDs at 650nm. It delivers 5mW per laser diode with 2.85 mW/cm² irradiance. The treatment time is 20 minutes daily versus the predicate's 25 minutes daily. All specifications remain within the range of cleared predicate devices K231153 and K240456.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-57 (non-laser light source equipment), IEC 60825-1 (laser product safety), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), and ISO 10993-5 and ISO 10993-10 (biocompatibility).

The subject device is substantially equivalent because it uses identical design principles, indications for use, intended user population, and treatment modality (low-level laser and LED therapy) as the predicates. Minor wavelength and treatment duration differences (655±5nm vs 650nm; 20 mins vs 25 mins) are clinically insignificant and within the range of legally marketed devices. The biocompatibility, safety standards compliance, and performance testing demonstrate comparable safety and effectiveness profiles to predicates K231153 and K240456.