iCare ST500

Basic Information

• Brand Name: iCare ST500
• Primary DI: 06430033851920
• Version / Model: TA04
• Company Name: ICARE FINLAND OY
• Labeler DUNS: 651755092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-05
• Public Version: 1
• Public Version Date: 2025-12-15
• Public Version Status: New
• Public Device Record Key: d445dd10-f6c4-48d4-b366-fc2f02bcc78b

Device Description

iCare ST500 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: Yes
• 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
HKY	Tonometer, Manual	Ophthalmic	886.1930	2
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	06430033851920	GS1

Premarket Submissions

Submission Number	Supplement Number
K241447	000