FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CVUE ADVANCED DEFINITIVE
K Number: K100456
·
Decision Oct 28, 2010
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
14
Review Days
253
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Basic Information
- Device Name
- CVUE ADVANCED DEFINITIVE
- K Number
- K100456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unilens Corp., USA
- Date Received
- February 17, 2010
- Decision Date
- October 28, 2010
- 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 Unilens Corp., USA
| K Number | Device Name | ||
|---|---|---|---|
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | Oct 30, 2014 | Substantially Equivalent |
| K121652 | CVUE ADVANCED HYDRA VUE | Oct 5, 2012 | Substantially Equivalent |
| K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, | Apr 20, 2011 | Substantially Equivalent |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Sep 11, 2008 | Substantially Equivalent |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | Apr 13, 2005 | Substantially Equivalent |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | Jul 7, 2004 | Substantially Equivalent |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | Oct 17, 2000 | Substantially Equivalent |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Apr 10, 1996 | Substantially Equivalent |
| K960376 | FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |
| K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |