Red Light Hair Growth Cap (LP-RJVGRW-BLK)

The Red Light Hair Growth Cap is a wearable, over-the-counter home-use device that emits 660 nm red light from LEDs to treat androgenetic alopecia and promote hair growth. It is indicated for males with Norwood-Hamilton Classifications IIa-V hair loss patterns and females with Ludwig-Savin Scale I-1 to I-4, II-1, II-2, or frontal patterns, all with Fitzpatrick Skin Types I-IV. The portable device comprises a soft textile cap, controller, AC adaptor, and USB cable, with treatment times adjustable from 10 to 30 minutes per day.

The subject device delivers 660 nm red light at 1.63 mW/cm² intensity with a treatment dose of 0.98–2.94 J/cm², operates on 100–240 VAC power, and uses software-controlled timer logic for treatment duration. Compared to the predicate devices (CurrentBody Skin MZ-07 and Biophotas Celluma RESTORE), the wavelength and intensity are very similar, with slight variations in treatment dose and electrical power specifications that do not raise new safety or effectiveness concerns.

IEC 60601-1:2020 (general medical electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2020 (home healthcare environment requirements), IEC 60601-2-57:2011 (non-laser light source therapeutic equipment), and IEC 62471:2006 (photobiological safety of lamps). Software was verified and validated to FDA guidance on Basic Documentation level.

The subject device is substantially equivalent because it shares identical intended use, indications, product code (OAP), device classification (Class II), and regulatory citation (21 CFR 890.5500) with legally marketed predicate devices. The design principle, energy type (LEDs), target anatomical site (scalp), wavelength (660 nm), and treatment parameters (duration, intensity, dose) are either identical or sufficiently similar that minor variations do not raise new questions about safety or effectiveness. All electrical safety and photobiological standards are met, and no clinical testing was required given the non-clinical performance data and predicate equivalence.