DeviceClearance

THE WAVE DIGITAL PHACO SYSTEM— 510(k) K981989

Substantially Equivalent

Circuit Tree

FDA 510(k) clearance K981989 for THE WAVE DIGITAL PHACO SYSTEM, Substantially Equivalent on 1998-08-25. Applicant: Circuit Tree.

Clearance details

Applicant
Circuit Tree
Product code
Code HQC
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Juan Capistrano, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HQC

product code HQC
Injury
2,378
Malfunction
8,768
Total
11,146

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.