MONITOR CO2 LASER SURGICAL SYSTEM— 510(k) K840145

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K840145 for MONITOR CO2 LASER SURGICAL SYSTEM, Substantially Equivalent on 1984-04-25. Applicant: Cooper Lasersonics, Inc..

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1984-01-13
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.