Icare Tonometer TA01I
by Tiolat OY
510(k) K063873
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063873 | Date23 May 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HKY
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1930
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Icare Tonometer TA01I is a manual intraocular pressure (IOP) measurement device classified as a tonometer. It is designed to provide objective and accurate readings of IOP, a critical diagnostic parameter in ophthalmology for assessing glaucoma and other eye conditions. This device operates on a non-contact or low-contact principle, allowing measurements in both sitting and standing positions, which enhances accessibility for diverse patient populations, including children and individuals with limited mobility.
The Icare Tonometer TA01I is supplied as a reusable medical device intended for clinical use in ophthalmic settings. It has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (HKY). The device is not specified as sterile but requires proper cleaning and maintenance as outlined in its user manual. No MRI safety information is provided, and its durability is noted for long-term clinical use. Authorizations include FDA clearance (K063873) and compliance with regulation number 886.1930.
Questions
AI-generated answers, 20 Sep 2026
How is the Icare Tonometer TA01I different from other manual tonometers in terms of patient accessibility and ease of use?
The Icare Tonometer TA01I is designed for low-contact or non-contact measurements, allowing it to be used in both sitting and standing positions. This flexibility makes it particularly accessible for diverse patient populations, including children and individuals with limited mobility, ensuring ease of use in clinical settings without requiring the patient to adopt a specific position.
Is the Icare Tonometer TA01I intended for single-use or reusable applications, and what maintenance is required?
The Icare Tonometer TA01I is supplied as a reusable medical device, intended for long-term clinical use. While it is not specified as sterile, proper cleaning and maintenance as outlined in the user manual are essential to ensure accuracy and hygiene between uses.
What regulatory pathway was followed for FDA clearance of the Icare Tonometer TA01I, and what classification does it hold?
The Icare Tonometer TA01I received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device (product code: HKY). This classification is based on its intended use as a manual tonometer for measuring intraocular pressure in ophthalmic settings.
Can the Icare Tonometer TA01I be used in environments where MRI machines are present, and what is its intended clinical specialty?
The device does not provide explicit MRI safety information, so its use near MRI machines should be evaluated carefully to avoid potential interference or safety risks. Clinically, it is intended for ophthalmic use, specifically for measuring intraocular pressure to assess conditions like glaucoma.