Recall Z-2067-2015— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2015-03-25, terminated 2015-07-14. It names 2 FDA 510(k) clearances: K133358, K032085. Product: Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: 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: Accessories to the GYC-1000 laser were missing Laser Aperture labels..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-25
- Terminated
- 2015-07-14
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K133358 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
- K032085 — GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K-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
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: 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
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.