CANDELA MINIBRUSH— 510(k) K932930

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K932930 for CANDELA MINIBRUSH, Substantially Equivalent on 1993-10-05. Applicant: Candela Laser Corp..

Clearance details

Applicant: Candela Laser Corp.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-15
Decision date: 1993-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.