Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo— 510(k) K212630

Substantially Equivalent

Ellex Medical Pty, Ltd.

FDA 510(k) clearance K212630 for Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo, Substantially Equivalent on 2021-12-16. Applicant: Ellex Medical Pty, Ltd..

Clearance details

Applicant: Ellex Medical Pty, Ltd.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2021-08-19
Decision date: 2021-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Adelaide, AU

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.