CANDELA STONE BASKETS— 510(k) K884738

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K884738 for CANDELA STONE BASKETS, Substantially Equivalent on 1989-02-09. Applicant: Candela Laser Corp..

Clearance details

Applicant: Candela Laser Corp.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1988-11-14
Decision date: 1989-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.