TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

The Aduro Hair Growth (Models M-130, M-300) and Trudermal Halo Hair Growth System (Model M-180A) are head-mounted devices designed to be worn with a baseball cap that emit red light (LED and/or laser) to treat androgenetic alopecia and promote hair growth. They are indicated for males with Norwood-Hamilton Classifications IIa-V and females with Ludwig-Savin Scale I-1 to I-4, II-1, II-2, or frontal patterns of hair loss, with Fitzpatrick Skin Types I-IV.

Models M-130 and M-180A emit red LEDs at 660nm±10nm for 10-minute treatments delivering 3J/cm² at <5 mW/cm². Model M-300 combines red LEDs and laser at 650nm±10nm for 25-minute treatments delivering 7.5J/cm². All three models use rechargeable lithium batteries, automatic shutoff after treatment, and uniform light distribution across 130-200 LEDs/lasers. The devices use software controllers and timers for treatment management.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-1-11:2015/AMD1:2020 (home healthcare environment), IEC 60601-2-57:2011 (non-laser light source equipment), IEC 62471:2006 (photobiological safety), ISO 10993-5/10/23 (biocompatibility), IEC 62366-1 and IEC 60601-1-6 (usability), and FDA guidance on device software functions.

The subject devices are substantially equivalent to predicates K242363 (HIGHERDOSE Red Light Hat) and K213025 (Laser hair growth helmet) because they share identical design principles, intended use, indications for use, functions, and materials. Key parameters—wavelength (red light 650-660nm), dose (3-7.5J/cm²), treatment protocol (every other day for 16 weeks), and light source uniformity—are equivalent or fall within acceptable ranges compared to predicates. Non-clinical testing confirms the devices meet all applicable safety and performance standards. The differences in LED/laser counts and treatment times do not raise new safety or effectiveness questions.