NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI— 510(k) K111493

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K111493 for NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI, Substantially Equivalent on 2011-07-27. Applicant: Nidek Co., Ltd..

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 2011-05-31
Decision date: 2011-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQB

product code HQB

Other: 2
Total: 2

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.