LENSX 550 LASER SYSTEM— 510(k) K082947

Substantially Equivalent

Lensx Lasers, Inc.

FDA 510(k) clearance K082947 for LENSX 550 LASER SYSTEM, Substantially Equivalent on 2009-08-14. Applicant: Lensx Lasers, Inc..

Clearance details

Applicant: Lensx Lasers, Inc.
Product code: Code OOE
Advisory panel: Ophthalmic
Date received: 2008-10-02
Decision date: 2009-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOE

product code OOE

Injury: 1,104
Malfunction: 864
Total: 1,968

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.