R:GEN— 510(k) K220974

Substantially Equivalent

Lutronic Vision, Inc.

FDA 510(k) clearance K220974 for R:GEN, Substantially Equivalent on 2022-12-27. Applicant: Lutronic Vision, Inc..

Clearance details

Applicant: Lutronic Vision, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2022-04-04
Decision date: 2022-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, 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.