ANDELA DYNAMIC COOLING DEVICE— 510(k) K951033

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K951033 for ANDELA DYNAMIC COOLING DEVICE, Substantially Equivalent on 1996-08-15. Applicant: Candela Laser Corp..

Clearance details

Applicant: Candela Laser Corp.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1995-03-06
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.