Luneau Sterile Tonometer Separation Prisms
by Luneau SA
510(k) K023838
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023838 | Date20 Feb 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 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- Withdrawn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, 1 Oct 2026
The Luneau Sterile Tonometer Separation Prisms are a type of Tonometer, Manual, designed to measure intraocular pressure in ophthalmic examinations. These optical plastic prisms feature a transparent monobloc construction with one plane surface for contact with the eye and two small prisms that enable the ophthalmologist to observe two half-circles simultaneously, aiding in accurate tonometry readings.
Supplied as sterile, single-use devices, these prisms are intended for use with Goldmann applanation tonometers in clinical settings. They are classified as Class II medical devices under FDA regulation 886.1930 and have received FDA 510(k) clearance (K023838) under the Traditional 510(k) Review pathway. The prisms are packaged for sterile use and must be stored according to manufacturer guidelines to maintain integrity until use.
Other devices from Luneau SA
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of the Luneau Sterile Tonometer Separation Prisms?
These prisms are designed to assist ophthalmologists during intraocular pressure measurements using Goldmann applanation tonometers. The transparent monobloc construction with two small prisms allows simultaneous observation of two half-circles, improving the accuracy and reliability of tonometry readings by enhancing visualization of the corneal surface.
Are the Luneau Sterile Tonometer Separation Prisms reusable or single-use?
These prisms are explicitly marketed as sterile, single-use devices. Each unit is intended for one-time clinical use only to maintain sterility and prevent cross-contamination between patients. Discarding after use ensures compliance with infection control protocols.
How should the Luneau Sterile Tonometer Separation Prisms be stored?
The prisms must be stored according to the manufacturer’s guidelines to preserve their sterile integrity until use. This typically involves keeping them in their original packaging in a clean, dry environment, protected from moisture, dust, and direct sunlight. Avoid refrigeration unless specified, as excessive humidity or temperature fluctuations could compromise sterility.
Can these prisms be used with any Goldmann applanation tonometer?
Yes, the Luneau Sterile Tonometer Separation Prisms are specifically designed for compatibility with Goldmann applanation tonometers. Their optical construction is optimized to integrate seamlessly with the tonometer’s mechanism, ensuring accurate pressure readings while providing the dual half-circle viewing feature.
What regulatory pathway was followed for FDA clearance of these prisms?
The Luneau Sterile Tonometer Separation Prisms received FDA 510(k) clearance under the Traditional 510(k) Review pathway. They were classified as Class II medical devices under FDA regulation 886.1930, with a determination of substantial equivalence to a predicate device. The clearance number is K023838, filed in 2002 and decided in 2003.