LENSSX LASER SYSTEM— 510(k) K120732

Substantially Equivalent

Alcon Lensx, Inc.

FDA 510(k) clearance K120732 for LENSSX LASER SYSTEM, Substantially Equivalent on 2012-09-06. Applicant: Alcon Lensx, Inc..

Clearance details

Applicant: Alcon Lensx, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2012-03-09
Decision date: 2012-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, US

Download summary PDF View on FDA.gov ↗

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.