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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K261705

510(k) cleared

Hair Removal Device (R3C16-G Pro, R3C16-V Pro)

Shenzhen Jianchao Intelligent Technology Co., Ltd. · Aug 10, 2026 · K261705

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 2 other decisions in the tracker over the last 12 months: 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)), K252553 (Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)).

Questions & Answers

What did FDA clear under K261705?

K261705 is the FDA 510(k) for Hair Removal Device (R3C16-G Pro, R3C16-V Pro), submitted by Shenzhen Jianchao Intelligent Technology Co., Ltd.. FDA's decision date was Aug 10, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Hair Removal Device (R3C16-G Pro, R3C16-V Pro)?

Shenzhen Jianchao Intelligent Technology Co., Ltd., based in Shenzhen, is the applicant of record for K261705.

How long did the K261705 review take?

FDA received the submission on May 22, 2026 and issued its decision on Aug 10, 2026, 80 days later.

← All decisions in August 2026