Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

The Hair Growth Device is a portable, low-level laser therapy (LLLT) helmet used to promote hair growth in patients with androgenetic alopecia. It uses 650 nm visible red laser diodes (5 mW each) distributed throughout the helmet to treat the entire scalp. The device is indicated for females with Ludwig-Savin Classifications I-II and males with Norwood-Hamilton Classifications IIa-V, across Fitzpatrick skin types I-IV, and is sold over-the-counter.

The subject device uses 56, 88, 120, or 200 laser diodes at 650 nm ±20 nm wavelength, delivering 5 mW per diode with treatment duration of 30 minutes every 2 days for 16 weeks. Predicate devices use similar 650 nm wavelengths but vary in number of diodes (predicate: 200; references: 51–272) and treatment protocols. All devices are Class 3R per IEC60825-1 and operate at similar irradiance and fluence ranges, though the subject device has multiple models with different laser counts to accommodate different treatment intensities.

IEC 60601-1 (medical device safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 60601-1-11 (home healthcare), ISO 10993-5 and ISO 10993-10 (biocompatibility). The submission also references software validation, electromagnetic compatibility and electrical safety testing, laser safety verification, and performance testing.

The subject device has identical intended use and mechanism of action (LLLT at 650 nm for androgenetic alopecia) as the predicate iHelmet and reference devices. Although the subject device offers multiple laser counts (56–200) compared to the predicate's single 200-diode configuration, the applicant argues this creates a range of fluence and irradiance values that fall within or overlap the predicate devices' specifications, making them therapeutically equivalent. Dimensional and weight variations are claimed not to affect safety or effectiveness because all devices comply with the same IEC 60601-1 standards. Non-clinical testing (biocompatibility, EMC, laser safety, performance) demonstrated compliance with predefined acceptance criteria without clinical data.