MOLTENO3— 510(k) K062252

Substantially Equivalent

Iop, Inc.

FDA 510(k) clearance K062252 for MOLTENO3, Substantially Equivalent on 2006-09-27. Applicant: Iop, Inc..

Clearance details

Applicant: Iop, Inc.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 2006-08-03
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

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.