CANDEKA DUKATIR SETS— 510(k) K950635

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K950635 for CANDEKA DUKATIR SETS, Substantially Equivalent on 1995-03-01. Applicant: Candela Laser Corp..

Clearance details

Applicant: Candela Laser Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1995-02-13
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.