DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
FDA 510(k) clearance K161391 · decided 2016-11-30
Clearance details
- K-number
- K161391
- Device name
- DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-19
- Decision date
- 2016-11-30
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, 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
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|---|---|---|
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S164) | Alcon Laboratories, Inc. | 2026-07-08 |
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| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S165) | Alcon Laboratories, Inc. | 2026-07-02 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S087) | Alcon Laboratories, Inc. | 2026-05-29 |
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| Precision7; Precision7 for Astigmatism; Precision7 Multifocal (P220007/S007) | Alcon Laboratories, Inc. | 2026-03-11 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S162) | Alcon Laboratories, Inc. | 2026-03-02 |
| Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (P010019/S086) | Alcon Laboratories, Inc. | 2026-02-26 |