TonoVue

Basic Information

• Brand Name: TonoVue
• Primary DI: 04719876420046
• Version / Model: TonoVue
• Catalog Number: 700-C0612-031
• Company Name: CRYSTALVUE MEDICAL CORPORATION
• Labeler DUNS: 658841648
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-15
• Public Version: 1
• Public Version Date: 2026-04-23
• Public Version Status: New
• Public Device Record Key: 7d286d2a-46a1-4833-8a5e-02f598933d37

Device Description

Non-contact Tonometer

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: Yes
• 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
HKX	Tonometer, Ac-Powered	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67414	Ophthalmic tonometer, professional	An ophthalmic, electrically-powered device intended to be used by a healthcare professional to measure intraocular pressure (IOP) by exerting an external force against the eye, which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation), typically for the diagnosis of glaucoma. It may have a light contact with the eye, have a bench-top or hand-held design, and use various techniques (e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719876420046	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180820	000