Recall Z-2120-2014— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2014-05-16, terminated 2014-10-16. It names one FDA 510(k) clearance: K032085. Product: GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.. Reason: Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,.
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-16
- Terminated
- 2014-10-16
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Reason for recall
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
Data sourced from openFDA. This site is unofficial and independent of the FDA.