FDA Compliance

FDA Information & Regulatory Compliance

We are committed to ensuring that our products meet applicable regulatory requirements and quality standards.

Company Registration Information

• Facility Name: VisuScience Meditech Co., Ltd.
• Registration Number: 3027499529
• FEI Number: 3027499529
• Owner/Operator Number: 10088752

Device Listings

MeiboVue VMC-100

Product Name: MeiboVue Meibomian Gland Imaging Camera

• Listing Number: D514386
• Device Name: Camera, ophthalmic, general-use (VMC-100)
• Components: Aluminum, plastic, lens
• Intended Use: Used for capturing ocular images

Product Name: Smartphone Eye Imaging Adaptor

• Listing Number: D514761
• Device Name: AnterVue Smartphones Eye Imaging Adaptor (VPA-200)
• Components: Plastic, lens
• Intended Use: Used for assisting eye imaging

iFlo VEM-200

Product Name: iFlo Eye Mask

• Listing Number: D550982
• Device Name: Pack, hot or cold, reusable (iFlo Eye Mask, VEM-200)
• Components: Cotton fabric, plastic
• Intended Use: Used for warm compressing to the eyes

iExpressor VMF-100

Product Name: Ophthalmic Forceps

• Listing Number: D550975
• Device Name: Forceps, ophthalmic
• Components: Steel
• Intended Use: Used for clamping the eyelid

Compliance Statement

All listed products are registered with the U.S. Food and Drug Administration (FDA) in accordance with applicable regulations. Registration and listing information is publicly available through the FDA database.