Evolution Optiks Gains the US FDA’s 510(k) Clearance for Eye Examination Device
Shots:
- Following the European CE mark in Mar 2024, the company’s light field-powered subjective tele-refractor, LFR-260, has now obtained the US FDA’s 510(k) clearance
- The approval was supported by the data from a multi-center, open-label, 2×2 cross-over trial involving 108 patients who underwent a full routine eye examination
- The company’s LFR-260 is a digital device, operable remotely via tablet. It utilizes microlens arrays and high-density displays to create real-time, ray-traced, multi-focal optotypes with its QuadView technology displaying various prescriptions simultaneously enabling patients to make vision-based decisions
Ref: Evolution Optiks | Image: Evolution Optiks
Related News:- Innovent Reports the NMPA’s NDA Acceptance of IBI311 for Treating Thyroid Eye Disease
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
