CANDELA DIODE TRABECULOPLASTY LASER DTL— 510(k) K910612

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K910612 for CANDELA DIODE TRABECULOPLASTY LASER DTL, Substantially Equivalent on 1991-03-04. Applicant: Candela Laser Corp..

Clearance details

Applicant: Candela Laser Corp.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1991-02-12
Decision date: 1991-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.