SOLUTIS— 510(k) K130933

Substantially Equivalent

Quantel Medical

FDA 510(k) clearance K130933 for SOLUTIS, Substantially Equivalent on 2013-08-02. Applicant: Quantel Medical.

Clearance details

Applicant: Quantel Medical
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2013-04-04
Decision date: 2013-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, 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.