SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS— 510(k) K121127

Substantially Equivalent

Cynosure, Inc.

FDA 510(k) clearance K121127 for SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS, Substantially Equivalent on 2012-05-13. Applicant: Cynosure, Inc..

Clearance details

Applicant: Cynosure, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-04-13
Decision date: 2012-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Wesford, MA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.