LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS— 510(k) K122829

Substantially Equivalent

Lensar, Inc.

FDA 510(k) clearance K122829 for LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS, Substantially Equivalent on 2012-12-03. Applicant: Lensar, Inc..

Clearance details

Applicant: Lensar, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2012-09-17
Decision date: 2012-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.