Applanation Tonometer AT-2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182491 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 Applanation Tonometer AT-2 is a manual ophthalmic device designed to measure intraocular pressure (IOP) in the eye. It operates on the principle of applanation, where a flat surface is applied to the cornea to determine IOP based on the force required to flatten a defined corneal area. This measurement aids in diagnosing and monitoring glaucoma and other ocular conditions.
The AT-2 is supplied as a reusable device, intended for use in clinical settings such as ophthalmology offices or hospitals. It is not sterile upon packaging and requires cleaning and maintenance between uses. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance, MDD, and MDR authorisations. Compatibility is specified for use with certain slit lamps, such as the 2ZL/4ZL series, ensuring precise integration into existing ophthalmic examination workflows.
Frequently asked questions
Is the Applanation Tonometer AT-2 intended for single-use or can it be reused in a clinical setting?
The Applanation Tonometer AT-2 is designed as a reusable device for clinical use in ophthalmology offices or hospitals. Since it is not sterile upon packaging, it requires cleaning and maintenance between uses to ensure proper hygiene and functionality.
What types of slit lamps is the AT-2 compatible with for integration into existing ophthalmic examination workflows?
The AT-2 is specifically compatible with certain slit lamp models, such as the 2ZL and 4ZL series, ensuring seamless integration into existing ophthalmic examination workflows for precise intraocular pressure measurements.
How is the Applanation Tonometer AT-2 regulated, and what does this mean for its use in clinical practice?
The AT-2 is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, as well as MDD and MDR authorizations. This classification means it has undergone rigorous review to ensure safety and effectiveness for measuring intraocular pressure in clinical settings, adhering to strict manufacturing and performance standards.
What is the primary purpose of the AT-2, and how does it function to aid in diagnosing ocular conditions?
The AT-2 measures intraocular pressure (IOP) using the applanation method, where a flat surface flattens a defined area of the cornea. This measurement helps diagnose and monitor glaucoma and other ocular conditions by providing an objective assessment of pressure within the eye.
What special considerations should be taken into account when storing the Applanation Tonometer AT-2?
Since the AT-2 is reusable and not sterile upon packaging, proper storage involves maintaining cleanliness and following manufacturer guidelines for disinfection and maintenance. It should be stored in a dry, clean environment to prevent contamination and ensure longevity, as outlined in the device’s operational instructions.
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: 510(k) Premarket Notification - FDA, AT-2 Applanation Tonometer - Takagi Japan, TAKAGI's Z-type Applanation Tonometer AT-2 Coming Soon, Applanation Tonometer - Takagi Europe, 2ZL BG Slit Lamp Microscope & OM-6 Flat Base Launch
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182491 | Class II | Active |
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Manufacturer
- Manufacturer
- Takagi Seiko Co., Ltd.
Sources (2)
- FDA 510(k) K182491 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026