Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)— 510(k) K242059
Substantially EquivalentX-Cel Specialty Contacts, A Walman Optical Company
FDA 510(k) clearance K242059 for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A), Substantially Equivalent on 2024-08-14. Applicant: X-Cel Specialty Contacts, A Walman Optical Company.
Clearance details
- Applicant
- X-Cel Specialty Contacts, A Walman Optical Company
- Product code
- Code LPL
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Duluth, GA, US
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . 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.