AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k) clearance K071736 · decided 2008-01-04
Clearance details
- K-number
- K071736
- Device name
- AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-26
- Decision date
- 2008-01-04
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposab recall (Z-0350-2012) | Coopervision Inc. | 2012-01-11 |
| AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES F recall (Z-0044-2012) | CooperVision Inc. | 2011-10-14 |