IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)— 510(k) K230824
Substantially EquivalentArt Optical Contact Lens, Inc.
FDA 510(k) clearance K230824 for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), Substantially Equivalent on 2023-09-06. Applicant: Art Optical Contact Lens, Inc..
Clearance details
- Applicant
- Art Optical Contact Lens, Inc.
- Product code
- Code LPL
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, 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.