Light Tree Ventures Europe B.V. · Class II · Cleared Dec 24, 2025
| K-number | K253349 |
| Device name | Hair Regrowth Cap (Model: T-119-HRC) |
| Applicant | Light Tree Ventures Europe B.V. |
| Product code | OAP |
| Device class | Class II |
| Decision date | Dec 24, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5500 |
The Hair Regrowth Cap (Model T-119-HRC) is a wearable LED light therapy device designed to treat androgenetic alopecia (male and female pattern hair loss) and promote hair growth. It consists of a soft textile cap embedded with LEDs powered by a rechargeable battery, operated via a built-in switch, and delivers approximately 10 minutes of daily treatment.
The device uses LED light phototherapy at a wavelength of 655±5 nanometers with measured irradiance of 18.4 mW/cm², delivering a 10-minute treatment session. These wavelength and irradiance characteristics are comparable to the predicate device (Revian Red), which operates at 620-660 nm with 19.1 mW/cm² irradiance.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment general safety), IEC 60601-2-57:2023 (non-laser light source equipment), IEC 62471:2006 (photobiological safety), and ISO 10993 series (biocompatibility testing for cytotoxicity, skin sensitization, and irritation).
The Hair Regrowth Cap is substantially equivalent to the legally marketed Revian Red device because it has identical intended use, same wavelength of emission, same treatment time, and same light energy delivery method (LED). The differences in design do not raise new questions of safety or effectiveness, and non-clinical testing demonstrates the device performs as safely and effectively as the predicate.
View the full FDA submission: accessdata.fda.gov