FDA cleared the Hair Removal Device (R3C16-G Pro, R3C16-V Pro) from Shenzhen Jianchao Intelligent Technology Co., Ltd. on Aug 10, 2026 under K261705, a special 510(k). The device falls under product code OHT, Light Based Over-The-Counter Hair Removal, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on May 22, 2026. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).
Shenzhen Jianchao Intelligent Technology Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K262352 (IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)), K262834 (Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)), K253833 (Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)).