DeviceClearance

K860011

Substantially Equivalent

NIDEK AC-2000 LASER SYSTEM

Applicant
Nidek, Inc.
Product code
HQB
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, 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, 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 →

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