NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT— 510(k) K133358
Substantially EquivalentNidek Co., Ltd.
FDA 510(k) clearance K133358 for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT, Substantially Equivalent on 2014-08-12. Applicant: Nidek Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nidek Co., Ltd.
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albignasego (Padova), IT
Recent devices under product code HQF
view allMore clearances from Nidek Co., Ltd.
view allAdverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133358
K-number listed on FDA's recall record- Z-2067-2015 — 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.
- Z-2068-2015 — Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133358.
Data sourced from openFDA. This site is unofficial and independent of the FDA.