Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
FDA 510(k) clearance K202036 · decided 2020-08-21
Clearance details
- K-number
- K202036
- Device name
- Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-23
- Decision date
- 2020-08-21
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MVN
- 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
| Record | Firm | Date |
|---|---|---|
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159) | Alcon Laboratories, Inc. | 2025-12-12 |
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| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157) | Alcon Laboratories, Inc. | 2025-08-25 |
| AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152) | Alcon Laboratories, Inc. | 2025-06-18 |
| AcrySof Posterior Chamber Intraocular Lenses (P930014/S154) | Alcon Laboratories, Inc. | 2025-03-21 |
| WaveLight EX500 Laser (P020050/S043) | Alcon Laboratories, Inc. | 2025-03-05 |
| AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155) | Alcon Laboratories, Inc. | 2025-02-14 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153) | Alcon Laboratories, Inc. | 2025-02-04 |