MyDay
FDA 510(k) clearance K190965 · decided 2019-04-29
Clearance details
- K-number
- K190965
- Device name
- MyDay
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-12
- Decision date
- 2019-04-29
- Days to decision
- 17 days
- Clearance type
- Special
- 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 |
|---|---|---|
| MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water cont recall (Z-2606-2025) | CooperVision, Inc. | 2025-09-19 |
| Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% wa recall (Z-2607-2025) | CooperVision, Inc. | 2025-09-19 |
| Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premiu recall (Z-2608-2025) | CooperVision, Inc. | 2025-09-19 |
| Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For recall (Z-1455-2025) | CooperVision, Inc. | 2025-03-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |