MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
FDA 510(k) clearance K051477 · decided 2006-03-10
Clearance details
- K-number
- K051477
- Device name
- MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
- Applicant
- Mi Gwang Contact Lens Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-03
- Decision date
- 2006-03-10
- Days to decision
- 280 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Go recall (Z-1257-06) | Hebron International, Inc. | 2006-07-26 |