FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR— 510(k) K070308

Substantially Equivalent

X-Cel Contacts

FDA 510(k) clearance K070308 for FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR, Substantially Equivalent on 2007-03-12. Applicant: X-Cel Contacts.

Clearance details

Applicant: X-Cel Contacts
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2007-02-01
Decision date: 2007-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, 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.