DEFINITIVE, FLEXLENS - SILICONE HYDROGEL— 510(k) K100443

Substantially Equivalent

X-Cel Contacts, Inc.

FDA 510(k) clearance K100443 for DEFINITIVE, FLEXLENS - SILICONE HYDROGEL, Substantially Equivalent on 2010-10-28. Applicant: X-Cel Contacts, Inc..

Clearance details

Applicant: X-Cel Contacts, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2010-02-17
Decision date: 2010-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

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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.