LENSAR Laser System fs 3D (LLS-fs 3D)— 510(k) K171337

Substantially Equivalent

Lensar, Inc.

FDA 510(k) clearance K171337 for LENSAR Laser System fs 3D (LLS-fs 3D), Substantially Equivalent on 2017-08-10. Applicant: Lensar, Inc..

Clearance details

Applicant: Lensar, Inc.
Product code: Code OOE
Advisory panel: Ophthalmic
Date received: 2017-05-08
Decision date: 2017-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.