DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
FDA 510(k) clearance K232921 · decided 2023-11-16
Clearance details
- K-number
- K232921
- Device name
- DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-19
- Decision date
- 2023-11-16
- Days to decision
- 58 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, recall (Z-3313-2024) | Alcon Research LLC | 2024-09-30 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S164) | Alcon Laboratories, Inc. | 2026-07-08 |
| Acrosof Posterior Chamber Intraocular Lens (P930014/S163) | Alcon Laboratories, Inc. | 2026-07-06 |
| 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 |
| AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof (P930014/S161) | Alcon Laboratories, Inc. | 2026-04-30 |
| 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 |