POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
FDA 510(k) clearance K004049 · decided 2001-05-23
Clearance details
- K-number
- K004049
- Device name
- POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
- Applicant
- Optech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-29
- Decision date
- 2001-05-23
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPTECH FRE-FLEX SOFT CONTACT LENS (P810050/S002) | Optech, Inc. | 1984-11-20 |
| OPTECH FRE-FLEX SOFT CONTACT LENS (P810050/S001) | Optech, Inc. | 1983-07-05 |