InstaClear Lens Cleaner— 510(k) K152531

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K152531 for InstaClear Lens Cleaner, Substantially Equivalent on 2016-01-15. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2015-09-03
Decision date: 2016-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.