Non-Contact Tonometer, Model FT-1000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073087 FDA 510(k)
- FDA Product Code
- HKX 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 Non-Contact Tonometer, Model FT-1000 is an ophthalmic device that measures intraocular pressure using a soft and silent air pulse. It is designed for patient comfort and provides accurate measurements through non-invasive means. The device features a touch screen alignment system and fully automatic measurement capabilities.
This tonometer is supplied by Tomey Corporation and is authorized under FDA 510K clearance with product code HKX. It is engineered for operator convenience and automatically adjusts intraocular pressure readings based on central corneal thickness. The device is manufactured in Tokyo, Japan, and is classified under the ophthalmic medical specialty.
Frequently asked questions
What is the purpose of the FT-1000 Non-Contact Tonometer?
The FT-1000 is an ophthalmic device designed to measure intraocular pressure using a soft and silent air pulse, providing accurate measurements through non-invasive means for patient comfort.
How is the FT-1000 Non-Contact Tonometer supplied?
The device is supplied by Tomey Corporation and features a touch screen alignment system with fully automatic measurement capabilities, designed for operator convenience.
What is the regulatory status of the FT-1000 Non-Contact Tonometer?
The FT-1000 is authorized under FDA 510K clearance with product code HKX and is classified under the ophthalmic medical specialty, manufactured in Tokyo, Japan.
How does the FT-1000 adjust intraocular pressure readings?
The device automatically adjusts intraocular pressure readings based on central corneal thickness, providing more accurate measurements tailored to individual patients.
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: FT-1000 Non-Contact Tonometer - Tomey USA, Tomey FT-1000 Non-Contact Tonometer for Sale - US Ophthalmic, TOMEY Non Contact Tonometer FT-1000 - Ophthalmic Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073087 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomey Corporation
Sources (1)
- FDA 510(k) K073087 24 fields · synced Sep 24, 2026