R:GEN Laser System— 510(k) K153769

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K153769 for R:GEN Laser System, Substantially Equivalent on 2016-10-05. Applicant: Lutronic Corporation.

Clearance details

Applicant: Lutronic Corporation
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2015-12-30
Decision date: 2016-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goyang-Si, KR

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.