FDA Product Code OHT: Light Based Over-the-counter Hair Removal

Light-based hair removal has become one of the most popular non-invasive cosmetic procedures. FDA product code OHT covers over-the-counter light-based hair removal devices for home use.

These devices use intense pulsed light or laser energy to target melanin in the hair follicle, generating heat that inhibits future hair growth. They are designed for consumer use without professional supervision and cleared for use on specific body areas.

OHT devices are Class II medical devices, regulated under 21 CFR 878.4810 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Shenzhen Ulike Smart Electronics Co., Ltd., Cyden Limited and Shenzhen Mlay Intelligent Technology Co., Ltd..