NIDEK MULTICOLOR LASER PHOTOCOAGULATOR— 510(k) K110228

Substantially Equivalent

Nidek Incorporated

FDA 510(k) clearance K110228 for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR, Substantially Equivalent on 2011-02-23. Applicant: Nidek Incorporated.

Clearance details

Applicant: Nidek Incorporated
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 2011-01-26
Decision date: 2011-02-23
Decision: Substantially Equivalent
Clearance type: Special
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.