FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
K Number: K180398
·
Decision Apr 10, 2018
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
43
Review Days
56
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Basic Information
- Device Name
- Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
- K Number
- K180398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Laboratories, Inc.
- Date Received
- February 13, 2018
- Decision Date
- April 10, 2018
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Alcon Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Feb 13, 2026 | Substantially Equivalent |
| K252682 | LenSx Laser System (8065000944) | Sep 24, 2025 | Substantially Equivalent |
| K243896 | LenSx Laser System (8065998162) | Apr 28, 2025 | Substantially Equivalent |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Jan 13, 2025 | Substantially Equivalent |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Dec 4, 2024 | Substantially Equivalent |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Jun 21, 2024 | Substantially Equivalent |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Jan 10, 2024 | Substantially Equivalent |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Dec 29, 2023 | Substantially Equivalent |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Nov 16, 2023 | Substantially Equivalent |
| K230785 | Precision1, Precision1 for Astigmatism | Apr 20, 2023 | Substantially Equivalent |