F 900 Tonometer
by C.S.O. S.R.L. 510(k)
Active
510(k) K022054
Overview
The F 900 is a manual tonometer, a device used to measure intraocular pressure within the eye. Intraocular pressure assessment is critical for diagnosing and managing glaucoma and other ocular conditions. This instrument provides quantitative readings to aid in clinical decision-making for ophthalmic evaluations.
The F 900 is supplied as a reusable medical device, intended for use in clinical settings such as ophthalmology offices and hospitals. It adheres to FDA clearance under the Traditional 510(k) pathway, classified as a Class II device (regulation number 886.1930). The device is not specified as MRI-safe or sterile upon packaging, requiring proper cleaning and maintenance between uses to ensure accuracy and hygiene. No additional regulatory markings beyond the FDA clearance are indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022054 | Date6 Aug 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- F 900
- 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
Other devices from C.S.O. S.R.L.
Questions
What is the F 900 manual tonometer used for?
The F 900 manual tonometer is designed to measure intraocular pressure (IOP) within the eye. Accurate IOP readings are essential for diagnosing and monitoring glaucoma and other ocular conditions, helping clinicians make informed decisions during ophthalmic evaluations.
Is the F 900 reusable or single-use?
The F 900 is a reusable medical device. It is intended for use in clinical settings such as ophthalmology offices and hospitals, where it can be cleaned and maintained between uses to ensure accuracy and hygiene. Proper cleaning protocols are required to prevent cross-contamination and preserve functionality.
Does the F 900 come sterile?
No, the F 900 is not supplied sterile. It is a reusable device, and sterility is not maintained between uses. Clinicians must follow manufacturer guidelines for cleaning and disinfection to ensure safe and accurate operation.
What regulatory pathway does the F 900 follow?
The F 900 manual tonometer is FDA-cleared under the Traditional 510(k) pathway and classified as a Class II device (regulation number 886.1930). This classification indicates it has been determined to be substantially equivalent to a legally marketed device and requires compliance with specific regulatory requirements.
How should the F 900 be stored?
The F 900 should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Since it is a reusable device, it should be disinfected and properly maintained between uses. Follow the manufacturer’s instructions for storage to ensure longevity and accuracy of the device.