R:GEN— 510(k) K220974

Name: FDA 510(k) clearance K220974
Creator: U.S. Food and Drug Administration
Published: 2022-12-27

Substantially Equivalent

Lutronic Vision, Inc.

FDA 510(k) clearance K220974 for R:GEN, Substantially Equivalent on 2022-12-27. Applicant: Lutronic Vision, Inc.. Device class: 2.

Clearance details

Applicant: Lutronic Vision, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
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 ↗

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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.