# K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: May 3, 2013 after 373 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913067 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063472: Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200, Meda, Ltd. (2007) Summary page 1.

## Most influential descendants
- K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology (2015), 0 descendants of its own

## Indications for use
The MD-1000A/P is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT). The MD-1000A is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD) and lens thickness (LT). The MD-i OQOP is used for ophthalmology to measure comneal thickness (CT). The device should be operated by trained doctors. It should be used cautiously to patients without independent behavior abilities. Cornea trauma or inflammation patients are prohibited to use the device.

Source page: https://510kreport.com/device/K121243
Methodology: https://510kreport.com/methodology