HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES— 510(k) K043540
Substantially EquivalentWestcon Contact Lens Co., Inc.
FDA 510(k) clearance K043540 for HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES, Substantially Equivalent on 2005-02-01. Applicant: Westcon Contact Lens Co., Inc..
Clearance details
- Applicant
- Westcon Contact Lens Co., Inc.
- Product code
- Code LPL
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grnad Junction, CO, 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.