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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 / March 2026 / K253822

510(k) cleared

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Zhuhai Fitlens Medical Technology Co., Ltd. · Mar 27, 2026 · K253822

FDA cleared the GPA (hexafocon A) Rigid Gas Permeable Contact Lenses from Zhuhai Fitlens Medical Technology Co., Ltd. on Mar 27, 2026 under K253822, a traditional 510(k). The device falls under product code HQD, Lens, Contact (Other Material) - Daily, regulated at 21 CFR 886.5916 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Nov 28, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zhuhai Fitlens Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253822?

K253822 is the FDA 510(k) for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses, submitted by Zhuhai Fitlens Medical Technology Co., Ltd.. FDA's decision date was Mar 27, 2026, under product code HQD (Lens, Contact (Other Material) - Daily).

Who makes the GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

Zhuhai Fitlens Medical Technology Co., Ltd., based in Zhuhai, is the applicant of record for K253822.

How long did the K253822 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Mar 27, 2026, 119 days later.

← All decisions in March 2026