K191846

Substantially Equivalent

MAXReach Laser Probe

Applicant
Vortex Surgical, Inc.
Product code
HQB
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chesterfield, MO, 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.