PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
FDA 510(k) clearance K061948 · decided 2006-11-22
Clearance details
- K-number
- K061948
- Device name
- PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-10
- Decision date
- 2006-11-22
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- MVN
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Norfolk, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx recall (Z-0542-2014) | CooperVision Inc. | 2013-12-19 |