WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / P220015

PMA approved

DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens

Tianjin MasterVision Technology Co., Ltd. · Aug 5, 2026 · P220015

FDA approved the DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens from Tianjin MasterVision Technology Co., Ltd. on Aug 5, 2026 under P220015, an original premarket approval. The device falls under product code NUU, Lens, Contact, Orthokeratology, Overnight, regulated at 21 CFR 886.5916 as a Class 3 device. The review panel was Ophthalmic.

FDA logged the submission as received on Sep 13, 2022. The decision came 1422 days later.

This is the only decision on file for Tianjin MasterVision Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P220015?

P220015 is the FDA PMA for DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens, submitted by Tianjin MasterVision Technology Co., Ltd.. FDA's decision date was Aug 5, 2026, under product code NUU (Lens, Contact, Orthokeratology, Overnight).

Who makes the DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens?

Tianjin MasterVision Technology Co., Ltd., based in Tianjin, is the applicant of record for P220015.

How long did the P220015 review take?

FDA received the submission on Sep 13, 2022 and issued its decision on Aug 5, 2026, 1422 days later.

← All decisions in August 2026