PASCAL STREAMLINE 577 (WITH ACCESSORIES)— 510(k) K111108

Substantially Equivalent

Topcon Medical Laser Systems, Inc.

FDA 510(k) clearance K111108 for PASCAL STREAMLINE 577 (WITH ACCESSORIES), Substantially Equivalent on 2011-08-11. Applicant: Topcon Medical Laser Systems, Inc..

Clearance details

Applicant: Topcon Medical Laser Systems, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2011-04-20
Decision date: 2011-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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.