KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES— 510(k) K140362

Substantially Equivalent

Katalyst Surgical, LLC

FDA 510(k) clearance K140362 for KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES, Substantially Equivalent on 2014-09-15. Applicant: Katalyst Surgical, LLC.

Clearance details

Applicant: Katalyst Surgical, LLC
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2014-02-12
Decision date: 2014-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

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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.