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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 / April 2026 / K260017

510(k) cleared

Picosecond Nd:YAG Laser Systems (Model: HS-298)

Shanghai Apolo Medical Technology Co., Ltd. · Apr 9, 2026 · K260017

FDA cleared the Picosecond Nd:YAG Laser Systems (Model: HS-298) from Shanghai Apolo Medical Technology Co., Ltd. on Apr 9, 2026 under K260017, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, 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 Jan 5, 2026. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shanghai Apolo Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260256 (Q-Switched Nd: YAG Laser Systems).

Questions & Answers

What did FDA clear under K260017?

K260017 is the FDA 510(k) for Picosecond Nd:YAG Laser Systems (Model: HS-298), submitted by Shanghai Apolo Medical Technology Co., Ltd.. FDA's decision date was Apr 9, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Picosecond Nd:YAG Laser Systems (Model: HS-298)?

Shanghai Apolo Medical Technology Co., Ltd., based in Shanghai, is the applicant of record for K260017.

How long did the K260017 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Apr 9, 2026, 94 days later.

← All decisions in April 2026

Sources