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Icare HOME Tonometer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163343

by Icare Finland Oy

Identifiers

510(k) Number
K163343 FDA 510(k)
FDA Product Code
HKY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1930 FDA 510(k)
Regulation Number
886.1930 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Icare HOME Tonometer is a handheld, non-contact intraocular pressure (IOP) measurement device designed for ophthalmic use. It employs a reusable probe with disposable tips to measure IOP without anesthesia, air puffs, or drops, making it suitable for patient self-monitoring in home settings. This device falls under the classification of a manual tonometer, specifically for assessing glaucoma risk or progression by tracking IOP variations over time.

Intended for single-use disposable tips (TP022) and reusable probe components, the Icare HOME Tonometer is supplied as a Class II medical device under FDA 510(k) clearance (K163343) and EU regulation 886.1930. It is non-sterile and intended for home use by patients under healthcare professional supervision. The device is MRI-unsafe due to its electronic components and must be stored in a clean, dry environment away from direct sunlight. No additional regulatory markings beyond the FDA clearance are specified.

Frequently asked questions

How does the Icare HOME tonometer differ from traditional intraocular pressure measurement methods like air puff tonometry or applanation tonometry?

The Icare HOME tonometer avoids the need for anesthesia, air puffs, or eye drops by using a reusable probe with single-use disposable tips. This makes it more comfortable for patients, especially those who need frequent monitoring at home, as it eliminates the discomfort and potential side effects associated with traditional methods like air puff tonometry or applanation tonometry.

Is the Icare HOME tonometer suitable for patients to use independently at home, or does it require professional supervision?

The device is explicitly designed for home use by patients, but it is intended to be used under the supervision of a healthcare professional. This ensures proper training and guidance on how to measure intraocular pressure accurately and safely, particularly for self-monitoring glaucoma risk or progression.

What are the storage requirements for the Icare HOME tonometer, and how should the disposable tips be handled?

The reusable probe of the Icare HOME tonometer must be stored in a clean, dry environment away from direct sunlight. The disposable tips (TP022) are non-sterile and intended for single-use, so they should be handled with care to avoid contamination before use.

Can the Icare HOME tonometer be used in an MRI environment, and if not, why?

No, the Icare HOME tonometer is not MRI-safe due to its electronic components. This means it should never be brought into an MRI scanner environment, as exposure to magnetic fields could damage the device or pose safety risks.

What regulatory pathways has the Icare HOME tonometer followed for approval, and where is it currently authorized?

The Icare HOME tonometer has received FDA 510(k) clearance under the classification of a Class II medical device (K163343) and is authorized under EU regulation 886.1930. This means it meets the necessary safety and performance standards for commercial distribution in the U.S. and EU markets.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: iCare HOME2 - iCare, iCare HOME2 | Measure IOP at Home | 24-hour dataiCare HOME2 - iCare, iCare tonometri HOME2 kotimittari - Kuomed Oy, PDF The easy-to-use Icare® tonometers revolutionize IOP home-monitoring, Home Tonometry - EyeWiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Icare Finland Oy

Sources (1)

  • FDA 510(k) K163343 24 fields · synced Sep 19, 2026