NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT— 510(k) K133358

Substantially Equivalent

Nidek 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..

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2013-10-31
Decision date: 2014-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albignasego (Padova), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.