Ultrasonic Pachymeter
by Precision Corneal Instruments
510(k) K921705
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921705 | Date16 Nov 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ultrasonic Pachymeter is a diagnostic device classified as an ultrasound imaging device (Device Type: IYO) used to measure corneal thickness. It employs ultrasonic waves to determine the central corneal thickness, a critical parameter in diagnosing and managing conditions such as glaucoma, keratoconus, and post-surgical evaluations. By providing precise single-point measurements, it aids clinicians in assessing corneal health and planning interventions. The device operates on the principle of applanation, where the cornea is gently flattened to ensure accurate thickness readings.
This handheld, portable device is intended for use in clinical settings such as ophthalmology offices, hospitals, and research laboratories. It is supplied as a reusable instrument, requiring proper sterilization between uses to maintain hygiene standards. The Ultrasonic Pachymeter is FDA-cleared under 510(k) clearance (K921705) and adheres to radiology advisory committee guidelines. No specific MRI safety information is provided, and its compact design facilitates easy integration into existing diagnostic workflows.
Questions
AI-generated answers, 1 Oct 2026
What is the Ultrasonic Pachymeter used for?
The Ultrasonic Pachymeter measures central corneal thickness using ultrasonic waves, which is essential for diagnosing and managing conditions like glaucoma, keratoconus, and evaluating corneal health post-surgery. It provides single-point measurements via applanation, where the cornea is gently flattened for accuracy.
Is the Ultrasonic Pachymeter single-use or reusable?
The device is designed as a reusable instrument. To ensure hygiene and safety between uses, it must be properly sterilized following manufacturer guidelines. This allows for repeated clinical use in ophthalmology offices, hospitals, or research settings.
How is the Ultrasonic Pachymeter supplied and where can it be used?
The Ultrasonic Pachymeter is supplied as a standalone handheld device, making it portable and easy to integrate into existing workflows. It is intended for clinical settings such as ophthalmology offices, hospitals, and research laboratories where corneal thickness assessments are required.
Does the Ultrasonic Pachymeter require any special storage conditions?
While the device itself does not have specialized storage requirements, it should be stored in a clean, dry environment to prevent damage or contamination. Since it is reusable, proper sterilization procedures must be followed before each use to maintain accuracy and hygiene.
What regulatory approval does the Ultrasonic Pachymeter hold?
The Ultrasonic Pachymeter is FDA-cleared under 510(k) clearance (K921705) and is classified as substantially equivalent to predicate devices. It adheres to radiology advisory committee guidelines, ensuring compliance with U.S. regulatory standards for ultrasound imaging devices.