Hidrocor, Hidrocharme, and Natural Colors— 510(k) K160472

Substantially Equivalent

Solotica

FDA 510(k) clearance K160472 for Hidrocor, Hidrocharme, and Natural Colors, Substantially Equivalent on 2016-08-10. Applicant: Solotica.

Clearance details

Applicant: Solotica
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2016-02-19
Decision date: 2016-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Paulo, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.