ESSILOR

Basic Information

• Brand Name: ESSILOR
• Primary DI: 08034028770517
• Version / Model: MYOPIA EXPERT 700
• Catalog Number: BMT00004
• Company Name: VISIA IMAGING SRL
• Labeler DUNS: 447668039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-04
• Public Version: 1
• Public Version Date: 2024-11-12
• Public Version Status: New
• Public Device Record Key: 9facdf7a-3d67-4bb5-853b-66c66d52db86

Device Description

BIOMETER - TOPOGRAPHER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXK	Device, Analysis, Anterior Segment	Ophthalmic	886.1850	2
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18038	Corneal topography system	An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08034028770517	GS1

Premarket Submissions

Submission Number	Supplement Number
K222933	000