FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
K Number: K010636
·
Decision Mar 23, 2001
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
24
Applicant Total
44
Review Days
18
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Basic Information
- Device Name
- FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
- K Number
- K010636
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ciba Vision Corporation
- Date Received
- March 5, 2001
- Decision Date
- March 23, 2001
- Product Code
- MVN
- 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 |
|---|---|---|---|
| MVN | Lens, Contact, (Disposable) | FDA class 2 | Ophthalmic |
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Other Clearances by Ciba Vision Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | Jan 29, 2014 | Substantially Equivalent |
| K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | Feb 21, 2013 | Substantially Equivalent |
| K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | Mar 30, 2012 | Substantially Equivalent |
| K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Apr 14, 2009 | Substantially Equivalent |
| K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES | Feb 28, 2008 | Substantially Equivalent |
| K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Jan 24, 2008 | Substantially Equivalent |
| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | Nov 14, 2006 | Substantially Equivalent |
| K041820 | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE | Sep 9, 2005 | Substantially Equivalent |
| K050250 | AQUIFY MULTIPURPOSE SOLUTION | Aug 10, 2005 | Substantially Equivalent |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | May 27, 2005 | Substantially Equivalent |