Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
FDA 510(k) K153643 · Alcon Laboratories, Inc.
510(k) numberK153643
Submission
- Device name
- Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
- Applicant
- Alcon Laboratories, Inc.
Fort Worth, TX, US - Received
- December 21, 2015
- Decision date
- January 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code LPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional | INTEROJO, Inc. | 05/29/2026SE |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 05/21/2026SE |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special | Pegavision Corporation | 05/19/2026SE |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional | Geo Medical Co., Ltd. | 04/29/2026SE |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 03/19/2026SE |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 03/13/2026SE |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | Alcon Laboratories, Inc. | 02/13/2026SE |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional | Bruno Vision Care, LLC | 12/23/2025SE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 10/07/2025SE |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | Yung Sheng Optical Co., Ltd. | 09/25/2025SE |
More from Yung Sheng Optical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | 02/13/2026SE |
| K252682 | LenSx Laser System (8065000944)OOE · Special | 09/24/2025SE |
| K243896 | LenSx Laser System (8065998162)OOE · Traditional | 04/28/2025SE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…LPL · Special | 01/13/2025SE |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | 12/04/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | 01/10/2024SE |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
Questions and answers
When was Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives cleared by the FDA?
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (K153643) received a 510(k) decision of Substantially Equivalent on January 20, 2016, 30 days after the submission was received.
What is the product code of K153643?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.