EyesOpen Tonometer
by Eye-Deas, LLC 510(k)
Active
510(k) K032769
Overview
The EyesOpen Tonometer is a manual intraocular pressure measurement device designed for ophthalmic use. It employs a solid-state force transducer and microprocessor to accurately assess intraocular pressure (IOP) during eye examinations or when elevated IOP is suspected.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings by trained ophthalmologists. It adheres to FDA regulatory standards under 510(k) clearance (K032769) and falls under the classification of Class II devices (HKY), with a traditional review process. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032769 | Date23 Sep 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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
Questions
Is the EyesOpen Tonometer designed for single-use or can it be reused in a clinical setting?
The EyesOpen Tonometer is explicitly described as a reusable medical instrument, intended for use in clinical settings by trained ophthalmologists. Since it is not labeled as single-use, it must be properly cleaned, disinfected, and maintained between uses to ensure accuracy and patient safety. No specific sterility claims are provided, so adherence to standard reprocessing protocols for reusable ophthalmic devices is recommended.
What types of clinical environments or specialties would benefit most from using the EyesOpen Tonometer?
The EyesOpen Tonometer is categorized under ophthalmic medical specialty and falls under the HKY product code, which aligns with intraocular pressure measurement devices. It is designed for use by trained ophthalmologists during eye examinations or when elevated intraocular pressure (IOP) is suspected. Clinics, hospitals, or private ophthalmology practices focused on glaucoma screening, routine eye checks, or diagnostic evaluations would find it most useful.
How is the EyesOpen Tonometer regulated, and what does that mean for purchasing or using it?
The EyesOpen Tonometer is classified as a Class II device under FDA regulations and has received 510(k) clearance (K032769) through a traditional review process. This means it has been determined to be substantially equivalent to a legally marketed device already on the market. For buyers or clinicians, this indicates it meets FDA safety and performance standards, but it does not imply any specific clinical indication—only that it complies with regulatory requirements for manual tonometers in ophthalmic use.
Are there any special storage requirements for the EyesOpen Tonometer?
The provided data does not specify any unique storage requirements for the EyesOpen Tonometer beyond standard handling for reusable medical devices. Since it is a reusable instrument, it should be stored in a clean, dry environment, protected from contamination, and kept away from extreme temperatures or direct sunlight. If used in a multi-user setting, ensure it is properly disinfected and maintained according to manufacturer guidelines to preserve its accuracy and functionality.