POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)— 510(k) K004049
Substantially EquivalentOptech, Inc.
FDA 510(k) clearance K004049 for POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS), Substantially Equivalent on 2001-05-23. Applicant: Optech, Inc.. Device class: 2.
Clearance details
- Applicant
- Optech, Inc.
- Product code
- Code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Junction, CO, US
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More clearances from Optech, Inc.
view allAdverse 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.