FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K Number: K133627
·
Decision Dec 23, 2013
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
472
Applicant Total
87
Review Days
27
Basic Information
- Device Name
- AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
- K Number
- K133627
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COOPERVISION, INC.
- Date Received
- November 26, 2013
- Decision Date
- December 23, 2013
- 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 COOPERVISION, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | May 30, 2013 | Substantially Equivalent |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | Apr 3, 2012 | Substantially Equivalent |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | Dec 2, 2011 | Substantially Equivalent |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | Dec 2, 2011 | Substantially Equivalent |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | Sep 15, 2011 | Substantially Equivalent |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT | Jun 29, 2011 | Substantially Equivalent |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Jan 5, 2010 | Substantially Equivalent |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | Sep 29, 2008 | Substantially Equivalent |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Jan 4, 2008 | Substantially Equivalent |