NAVILAS LASER SYSTEM— 510(k) K091064

Substantially Equivalent

Od-Os GmbH

FDA 510(k) clearance K091064 for NAVILAS LASER SYSTEM, Substantially Equivalent on 2009-10-27. Applicant: Od-Os GmbH.

Clearance details

Applicant: Od-Os GmbH
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2009-04-14
Decision date: 2009-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, 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.