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Ophthalmic YAG Laser System
NIDEK CO.,LTD. · Model YC-200 · UDI-DI 04987669101452
10
510(k) clearances
1,529
Adverse events
32
Recalls
62
Facilities
Description
The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | Beaver-Visitec International, Inc. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. Th |
| 2023-03-16 | Ellex Medical Pty Ltd. | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output |
| 2021-04-14 | Dutch Ophthalmic USA, Inc. | Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01 |
| 2016-07-15 | Topcon Medical Laser Systems, Inc | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fun |
| 2016-02-01 | Laserex Systems Inc. | The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented. |
| 2014-12-18 | Ziemer Usa Inc | The devices were not shipped with the Starter Kits. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-08-15 | Lumenis, Inc. | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.