PSLT for PASCAL Streamline— 510(k) K171488

Name: FDA 510(k) clearance K171488
Creator: U.S. Food and Drug Administration
Published: 2017-11-27

Substantially Equivalent

Topcon Medical Laser Systems, Inc.

FDA 510(k) clearance K171488 for PSLT for PASCAL Streamline, Substantially Equivalent on 2017-11-27. Applicant: Topcon Medical Laser Systems, Inc.. Device class: 2.

Clearance details

Applicant: Topcon Medical Laser Systems, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2017-05-22
Decision date: 2017-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livermore, CA, US

Download summary PDF View on FDA.gov ↗

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K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar2018-05-25
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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.