Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter
by Meda Co., Ltd. EUDAMED510(k)
Active
510(k) K121243
Overview
The Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter is a diagnostic device classified as an ultrasonic pachymeter and ultrasonic biometer, used to measure corneal thickness and ocular axial length. It employs ultrasound technology to provide precise measurements essential for preoperative planning in refractive surgery and intraocular lens calculations.
This device is supplied as a reusable medical instrument and is intended for use in clinical ophthalmology settings. It requires proper calibration and maintenance to ensure accuracy, with no specific sterility requirements stated beyond standard cleaning protocols. The device is authorised under FDA 510K and MDR regulatory pathways, adhering to safety and performance standards for diagnostic ultrasound equipment in ophthalmology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK121243 | Date3 May 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
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
Other devices from Meda Co., Ltd.
Questions
What clinical measurements does this device provide, and why are they important for eye surgery planning?
This device measures corneal thickness and ocular axial length using ultrasound technology. Corneal thickness is critical for assessing suitability for refractive surgeries like LASIK or PRK, while axial length helps determine the correct power of intraocular lenses (IOLs) for cataract or refractive lens exchange procedures. Precise measurements reduce surgical risks and improve outcomes.
Is this device single-use or reusable, and what maintenance does it require?
The device is reusable and designed for clinical ophthalmology settings. Since it’s not sterile by default, it must follow standard cleaning protocols after each use to maintain hygiene. Regular calibration and maintenance are also required to ensure measurement accuracy, as specified in the manufacturer’s instructions.
How is this device regulated, and what does that mean for its use in practice?
The device is authorized under FDA 510k (traditional clearance via the Radiology Advisory Committee) and the EU MDR, confirming it meets safety and performance standards for diagnostic ultrasound in ophthalmology. This means it’s been evaluated for equivalence to existing devices and adheres to strict quality controls, but clinicians should still follow manufacturer guidelines for proper operation and maintenance.
What types of facilities or settings is this device intended for?
This device is designed for clinical ophthalmology settings, such as eye clinics, hospitals, or surgical centers where refractive surgery or cataract procedures are performed. Its reusable nature and ultrasound-based design make it suitable for environments with established infection control protocols and technical support for calibration.