KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES— 510(k) K121187

Substantially Equivalent

Katalyst Surgical, LLC

FDA 510(k) clearance K121187 for KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES, Substantially Equivalent on 2012-09-17. Applicant: Katalyst Surgical, LLC.

Clearance details

Applicant: Katalyst Surgical, LLC
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2012-04-19
Decision date: 2012-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.